- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646086
Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care (Tracking)
To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking).
The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women and men
- 18-64 years of age
- BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
- interest in joining a weight loss program
- have a computer, email, and wifi connection at home
- live in the Minneapolis/Saint Paul, Minnesota area
Exclusion Criteria:
- weight in the underweight to low normal (BMI < 22) or morbidly obese (BMI > 35) ranges
- current eating disorder or history of eating disorders
- current major depression or psychotic disorder diagnosis
- current cardiovascular disease or diabetes diagnosis
- current participation in a weight loss program
- current pregnancy
- previous weight loss surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: weekly weight tracking
12 month behavioral weight loss intervention
|
The intervention for all groups will follow a standard behavioral weight loss protocol.
Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period.
Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity.
Participants will be asked to keep daily diet and physical activity logs.
|
ACTIVE_COMPARATOR: daily weight tracking
12 month behavioral weight loss intervention
|
The intervention for all groups will follow a standard behavioral weight loss protocol.
Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period.
Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity.
Participants will be asked to keep daily diet and physical activity logs.
|
ACTIVE_COMPARATOR: no weight tracking
12 month behavioral weight loss intervention
|
The intervention for all groups will follow a standard behavioral weight loss protocol.
Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period.
Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity.
Participants will be asked to keep daily diet and physical activity logs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight Over Time
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
Weight (in kilograms) will be measured by study staff using a calibrated digital scales with participants wearing light clothing and no shoes.
Height (in centimeters) will be measured by study staff at baseline only using a portable stadiometer.
BMI (kg/m2) will be calculated from these measurements
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Measures
Time Frame: baseline
|
Age, sex, marital status, employment status, income level (categorical), race, and ethnicity will be assessed by self-report at baseline
|
baseline
|
Weight Tracking and Self-Monitoring Adherence
Time Frame: throughout intervention
|
Self-monitoring data on diet, physical activity, and weight from electronic or paper records will be recorded by interventionists at each session by compiling printouts of electronic records from websites supported by electronic monitoring tools, and by photocopying paper diaries for participants without electronic monitoring tools.
|
throughout intervention
|
Perceptions of Weight Tracking
Time Frame: 6 months, 12 months, 18 months, and 24 months
|
Participants complete an 8-item questionnaire to assess beliefs about their weight tracking assignment during the study.
The measure asks participants to rate daily, weekly, or no weight tracking in terms of ease, interest level, ability to remember, awareness, reward value, usefulness, understanding, and how motivated they are to engage in their assigned weight tracking frequency.
These items measure aspects of cue strength and motivational value, both of which are important to the process of behavior modification within a social-ecological frame (DiClemente et al., 2001; Elder et al., 2007)
|
6 months, 12 months, 18 months, and 24 months
|
Barriers to Weight Tracking
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
To elucidate factors that may impede engagement in daily or weekly weight tracking, participants will complete an assessment of perceived barriers to tracking weight.
Items for this measure were adapted from a measure of barriers to diet and exercise developed by a member of the research team and used in numerous weight loss studies These items will provide feedback on factors that may interfere with weight tracking and will provide guidance for adaptation and use of weight tracking instructions for future interventions.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Self-Efficacy for Weight Loss Behaviors
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
Self-efficacy for dietary intake, physical activity, and weight tracking behaviors will be assessed using a 15-item scale developed by members of the research team (Linde et al., 2006).
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Routine Health Habits
Time Frame: baseline, 12 months, and 24 months
|
Participants will complete brief screening items developed for the study to assess smoking status, sedentary behavior (television viewing) and days per week of engaging in weight control behaviors, including diet and physical activity monitoring.
Weight tracking frequency (never, every other month, monthly, weekly, or daily) and number of body weight scales at home will also be assessed.
|
baseline, 12 months, and 24 months
|
Dietary Intake
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Diet History Questionnaire (DHQ, 2010) is a food frequency questionnaire (FFQ) that assesses usual intake and portion size of 124 foods.
Responses are scored and analyzed using proprietary Diet*Calc software, which provides reasonable and valid estimates of macronutrient and caloric intake compared to 24-hour recall administrations (Millen et al., 2006) and alternate FFQ protocols (Subar et al., 2001).
A subset of 168 participants (50%; 56 per treatment condition) will be randomized at baseline to a 24-hr dietary recall protocol.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Physical Activity
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Paffenbarger Activity Questionnaire (PAQ; Paffenbarger et al., 1978) will be administered to provide an estimate of calories expended per week in leisure time physical activities.
The PAQ has been associated with weight loss outcomes in intervention trials (e.g., Harris et al., 1994).
A subset of 168 participants (50%; 56 per treatment condition) will be randomized to a 7-day accelerometer protocol at baseline and 12 months to enhance physical activity measurement during active weight loss, to elucidate any changes in daily patterning of activity that might occur during intervention.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Body Image
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Appearance Evaluation subscale of the Multidimensional Body-Self-Relations Questionnaire will assess body image.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Self-Esteem
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Rosenberg Self-Esteem Scale (Rosenberg, 1979) will rate global self-esteem and will be used to track well-being during the study.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Depression
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Beck Depression Inventory (BDI-II) will assess depressive symptoms that may change over the course of the study period.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Anxiety
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Beck Anxiety Inventory (BAI) will assess anxiety symptoms that may change over the study.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Mood States
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) will be administered as a momentary assessment of mood during randomly selected intervention sessions.
The measure, consisting of 60 adjectives that are rated on a five-point Likert scale (from 1=very slightly or not at all to 5=extremely), assesses positive and negative affect, basic negative emotions (fear, hostility, guilt, sadness), basic positive emotions (joviality, self-assurance, attentiveness), and additional mood states (shyness, fatigue, serenity, surprise).
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Life Events
Time Frame: baseline, 12 months, and 24 months
|
The Life Experiences Survey (Sarason et al., 1978) will assess a broad range of life changes and events that could affect participation in weight tracking or other study recommendations.
We expect that participants who endorse a greater number of stressful life events will have poorer adherence, will be less able to maintain tracking diaries, and will experience greater negative affect relative to those with fewer life events during the study (Dunkley et al., 2003; Sarason et al., 1978).
|
baseline, 12 months, and 24 months
|
Eating Disorder Symptoms
Time Frame: baseline, 6 months, 12 months, 18 months, and 24 months
|
Measures used to screen participants prior to study entry will be repeated during the trial for ongoing monitoring.
These include the Questionnaire on Eating and Weight Patterns to assess binge eating, and the SCOFF Eating Disorder Screening Questionnaire to assess presence of symptoms associated with anorexia or bulimia.
|
baseline, 6 months, 12 months, 18 months, and 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Linde, PhD, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1106S01462
- 1R01DK093586 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Weight Loss
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on 12 month behavioral weight loss intervention
-
University of VermontNational Institute of General Medical Sciences (NIGMS)Unknown
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brown... and other collaboratorsRecruiting
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of PittsburghCompleted
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Drexel UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
The University of Tennessee, KnoxvilleAmerican Heart AssociationCompleted
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Maryland Cigarette Restitution FundCompletedKidney Cancer | Breast Cancer | Rectal Cancer | Prostate Cancer | Bladder Cancer | Endometrial Cancer | Melanoma (Skin) | Gallbladder CancerUnited States
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI); Unrestricted research gift...Completed
-
Children's Hospital of PhiladelphiaNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Completed