Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment

Use of Pharmacotherapy to Improve Weight Loss in Early Non-responders to Behavioral Treatment

This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral Treatment; Drug: Placebo; Drug: Phentermine 15 MG

Detailed Description

Subjects will be a total of 150 adults, aged 21-70 years, with a body mass index (BMI) of 31 kg/m2 or above (28 kg/m2 with an obesity-related comorbidity). In phase 1, eligible subjects will complete questionnaires and an in-person baseline assessment of obesity-related behavioral characteristics (satiety, hunger, the relative reinforcing value of food [RRVfood], and impulsivity [delay discounting]), neuropeptides, and gastric emptying. After this baseline assessment, participants will begin an initial 4-week behavioral treatment (BT) "run-in" delivered individually in 20-30 minute weekly sessions (delivered virtually).

The primary goal of phase 1 will be to evaluate baseline satiety, postprandial change in GLP-1, and gastric emptying as predictors of percent weight loss after 4 weeks of BT. We will also examine whether these variables predict categorization as a suboptimal early responder to BT (e.g., <2.0% loss; co-primary outcome).

Secondary endpoints of phase 1 are percent weight loss from the start of the BT run-in (week -4) to randomization (week 0) and categorization as a suboptimal early responder, as predicted by additional behavioral characteristics (hunger as measured by VAS ratings, RRVfood as measured using a computer task, and impulsivity as measured using a delay discounting computer task) and neuropeptides (higher fasting ghrelin, lower fasting leptin, and lower postprandial changes in insulin and PYY).

In phase 2, suboptimal early responders (based on weight loss during the BT run-in) will be randomly assigned to 24 weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg). Both treatment groups will continue to attend 20-30 minute individual BT sessions (delivered virtually), weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Both treatment groups will also take once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.

The assessments administered at baseline - questionnaires, including behavioral testing, blood draws, and measurements of body weight - will be repeated at randomization (week 0) and at week 24.

The primary endpoint of phase 2 is change in body weight (i.e., % reduction in initial weight), as measured from randomization to week 24, among suboptimal early responders assigned to BT+P vs. BT+M. A randomized sample size of 50 non-responders (25 per group), assuming a 20% attrition rate, will give us 81.5% power to detect between-treatment group differences at week 24 of 4.5% (effect size: d = 0.82).

Secondary endpoints of phase 2 will include change in body weight in kg from randomization to week 24, as well as the portion of suboptimal early responders who achieve a post-randomization loss of ≥ 5% and ≥ 10% of initial body weight. We will also examine differences between suboptimal early responders treated with BT+M vs. BT+P in changes in hunger, satiety, the reinforcing efficacy of food, and impulsivity between randomization and week 24. A comparison will also be made in percent weight loss from randomization to week 24 between suboptimal early responders treated with BT+M and early responders treated with BT alone.

If you are interested in participating in this study, information and a link to contact the research team can be found here: https://clinicalresearch.itmat.upenn.edu/3XOX/ or you can call us at the numbers listed below.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Center for Weight and Eating Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)
2. Age ≥ 21 years and ≤ 70 years

3. Eligible female patients will be:

   • non-pregnant, evidenced by a negative urine pregnancy test
   • non-lactating
   • surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses).

4. Subjects must:

   • have a primary care provider (PCP) who is responsible for providing routine care
   • understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
   • plan to remain in the Philadelphia area for the next 9 months or more

Exclusion Criteria:

1. Pregnant or nursing, or plans to become pregnant in the next 9 months.
2. Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg)
3. Type 1 diabetes
4. Type 2 diabetes
5. A fasting blood glucose > 126 mg/dL (on second assessment after first elevated value)
6. History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, or heart block greater than first degree
7. Clinically significant hepatic or renal disease
8. Hyperthyroidism
9. Other thyroid disease, not controlled
10. History of malignancy (except for non-melanoma skin cancer) in past 5 years
11. Narrow angle glaucoma
12. Presence or history of marked agitation
13. Current severe major depressive episode (BDI-II score ≥ 29), current active suicidal ideation, or history of suicide attempts within the past 5 years.
14. Any severity of thought or bipolar disorder, or bulimia nervosa.
15. Psychiatric hospitalization within the past 6 months
16. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
17. Past year history of drug abuse
18. Use in the past 2 weeks of monoamine oxidase inhibitors
19. Current use of serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g. venlafaxine, duloxetine, desvenlafaxine, milnacipran, levomilnacipran).
20. Use in past 6 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
21. Loss of ≥ 5% of initial body weight within the past 6 months
22. History of (or plans for) bariatric surgery (e.g., roux en y gastric bypass, sleeve gastrectomy, gastric banding), endoscopic intragastric balloon, or aspire assist.
23. Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
24. Known or suspected allergy to sympathomimetic amines or related products
25. The receipt of any investigational drug within 6 months prior to this trial
26. Previous participation in this trial (e.g., randomized and failed to participate)
27. Changes to any chronic medication (type or dosage) within the past 3 months.
28. Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

Other Therapy: Subjects will be expected to use medications (prescribed by their PCP) to control traditional cardiometabolic risk factors (e.g., hypertension, hypercholesterolemia, etc) and other co-morbid conditions, with the exception of medications listed above under "exclusions." In all cases, the subjects' PCP will be asked at the study's outset to keep medication does constant throughout the study, whenever possible. Subjects will be expected to have been on their medication regimen (including the dose) for 3 months prior to beginning the BT program.

To be eligible to participate in the randomized phase of the trial, subjects must also:

1. Complete at least 3 out of 4 treatment sessions during the 4-week BT run-in and attend a randomization visit. Attending an in-person makeup session within one week of a missed visit will count as having attended the run-in visit.
2. Lose < 2.0% of initial weight during the 4-week BT run-in.

Early BT responders who lose>=2% during the BT run-in will be offered the same 24-week BT program, but will not receive study medication or be included in the randomized trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phase 2: Behavioral Treatment + Placebo; Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.	Behavioral: Behavioral Treatment; Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).; Other Names: Lifestyle modification; Behavioral weight loss; Drug: Placebo; The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.; Other Names: Placebo for medication
Active Comparator: Phase 2: Behavioral Treatment + Medication; Participants with suboptimal early weight loss in the BT run-in will then be randomly assigned to 24 additional weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg) in a double-blinded fashion. Both treatment groups will continue to attend individual BT sessions and will take a once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial.	Behavioral: Behavioral Treatment; Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).; Other Names: Lifestyle modification; Behavioral weight loss; Drug: Phentermine 15 MG; The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.; Other Names: Medication
Other: Phase 1: 4-week Behavioral Treatment Run-in; All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss <2% of initial weight after 4 weeks of BT. Early responders are those who lose >=2%. Only early non-responders will then be enrolled in the randomized trial.	Behavioral: Behavioral Treatment; Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).; Other Names: Lifestyle modification; Behavioral weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Percent Weight Loss	Co-primary outcomes - phase 1	Week -4 (start of BT run-in) to week 0 (randomization)
Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss	Co-primary outcomes - phase 1	Week -4 (start of BT run-in) to week 0 (randomization)
Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100.	Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety.	Baseline (week -5)
Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal	Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i.	Baseline
Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)	Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i.	Baseline
Phase 2: Percent Weight Loss	Primary outcomes - phase 2 Percent change from randomization in body weight	Week 0 (randomization) to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal	Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the hunger scale score at time i.	Baseline
Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned	Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum.	Baseline
Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay	Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.	Baseline
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire	Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite.	Baseline
Phase 1: Baseline Fasting Ghrelin	Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL)	Baseline
Phase 1: Baseline Fasting Leptin	Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting).	Baseline
Phase 1: Baseline Postprandial Change in Insulin During a Test Meal	Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i.	Baseline
Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal	Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i.	Baseline
Phase 2: Weight Loss (kg)	Secondary outcomes - phase 2	Week 0 (randomization) to week 24
Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24	Secondary outcomes - phase 2	Week 0 (randomization) to week 24
Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24	Secondary outcomes - phase 2	Week 0 (randomization) to week 24
Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal	Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i.	Week 0 (randomization) to week 24
Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal	Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min*(x(i) + x(i-1))/2) where x is the scale score at time i.	Week 0 (randomization) to week 24
Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay	Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.	Week 0 (randomization) to week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger)	Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger)	Baseline
Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency)	Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.	Baseline
Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale	Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food)	Baseline
Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS)	Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness	Baseline
Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale	Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness	Baseline
Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder	The potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1.	Baseline
Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced	Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings	Baseline
Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ)	Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating	Baseline
Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012)	Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers.	Baseline
Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL)	Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy	Baseline
Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES)	Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy	Baseline
Phase 1: Randomization Ball and Crawford Social Support Scale	Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support.	Randomization (week 0)
Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS)	Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms	Baseline
Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food	Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price.	Baseline
Phase 1: Baseline Sleep Hours Survey	Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep	Baseline
Phase 1: Baseline Perceived Stress Scale	Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress	Baseline
Phase 1: Baseline Anxiety as Measured by the GAD-7	Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety	Baseline
Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale	Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance.	Baseline
Phase 2: Change in Blood Pressure (Systolic)	Exploratory outcomes - phase 2. Systolic blood pressure	Week 0 (randomization) to week 24
Phase 2: Change in Pulse	Exploratory outcomes - phase 2. Pulse	Week 0 (randomization) to week 24
Phase 2: Change in Triglycerides	Exploratory outcomes - phase 2	Week 0 (randomization) to week 24
Phase 2: Change in HDL and LDL Cholesterol	Exploratory outcomes - phase 2. Reported here is HDL	Week 0 (randomization) to week 24
Phase 2: Change in Fasting Blood Sugar	Exploratory outcomes - phase 2. Fasting glucose.	Week 0 (randomization) to week 24
Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm)	Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, "appetite" was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.	Week 0 (randomization) to week 24
Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL)	Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24.	Week 0 (randomization) to week 24
Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9)	Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24.	Week 0 (randomization) to week 24
Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire	Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24.	Week 0 (randomization) to week 24

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jena S Tronieri, PhD, Perelman School of Medicine at the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Weight Loss; Body Weight; Signs and Symptoms; Incretins; Hormones; Anti-Obesity Agents; phentermine; Body Weight Changes; Appetitive Behavior; Hypoglycemic agents; Appetite Depressants
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic Agents; Central Nervous System Stimulants; Anti-Obesity Agents; Sympathomimetics; Appetite Depressants; Phentermine
• Other Study ID Numbers: 832077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No