- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560635
Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity
April 15, 2022 updated by: University of Colorado, Denver
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob).
Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks.
Eligible participants will have lost >10% body mass.
The reverse diet group will receive personalized caloric intake goals, increasing 2-3%/week.
The CON group will receive standard weight maintenance recommendations with matched contact.
At baseline and week 12, resting energy expenditure (REE), body mass and composition, subjective appetite, and food intake behaviors will be evaluated.
In addition to the pre- and post-intervention measures, body mass and adherence to reverse diet will be monitored weekly.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Denver, Anschutz Medical Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All ethnic groups and both genders
- Age: 21-70 years
- BMI: 18.5-40 kg/m2
- Weight loss of >10% body mass achieved within 4 weeks of enrollment in study.
Exclusion Criteria:
- Uncontrolled cardio metabolic disease such as: cardiovascular disease (CVD), diabetes mellitus, hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly, following established guidelines), renal disease (e.g. chronic kidney disease, polycystic kidney disease, nephritis, etc.), hepatic disease (e.g. cirrhosis, liver failure, fatty liver, jaundice, etc.), untreated thyroid disease (e.g. Grave's disease, Hashimoto's disorder, goiters, thyroid cancers, etc.), or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If these conditions become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
- Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
- Significant gastrointestinal disorders including: inflammatory bowel disease requiring treatment within the past year, chronic malabsorptive conditions, chronic diarrhea, or active gallbladder disease.
- Use of pharmacotherapy agents to achieve weight loss prior to study enrollment.
- Current treatment with medications known to significantly affect appetite, weight, energy metabolism, energy intake or energy expenditure. (e.g. systemic corticosteroids, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
- History of surgical or endoscopic procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve, intragastric balloons, aspiration therapy, etc); history of extensive bowel resection for other reasons.
- Currently pregnant, lactating or less than 6 months post-partum.
- Planning to become pregnant during study enrollment period
- Self-report of alcohol or substance abuse within the past 12 months.
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder, or score >20 on the EATS-26. Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation.
- Major psychiatric disorder (e.g. diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders).
- Current severe depression or history of severe depression within the previous year (based on reported history, study physician examination findings, and/or a score >21 on the CES-D). Participants meeting any of these criteria will be referred to their primary care physician and/or the emergency department (based upon study physician determined level of severity).
- Currently participating in or planning to participate in any formal weight loss programs or clinical trials.
- Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
- Unable or unwilling to undergo study procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants randomized to the CON condition will be informed of their estimated weight maintenance calorie needs (determined by multiplying their resting energy expenditure (REE) obtained from indirect calorimetry by an appropriate activity factor and advised to adhere to this calorie target, as is standard weight maintenance advice.
Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the diet protocol.
|
Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program.
This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll.
While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period.
Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease.
The informational handouts will be provided to participants, but not specifically covered in weekly meetings.
Groups will differ only in specific caloric prescriptions (described in the Arms section).
|
Experimental: Reverse Diet
Participants randomized to the reverse diet condition will receive specific caloric intake goals.
The initial caloric goal will be set at 2-3% above the level participants ended their weight loss diet at (via self-report).
Participants' caloric goals will increase at a rate of 2-3% per week.
Participants will be provided with a food scale and calorie tracking options and instructed on the importance of high adherence to the reverse diet protocol.
|
Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program.
This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll.
While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period.
Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease.
The informational handouts will be provided to participants, but not specifically covered in weekly meetings.
Groups will differ only in specific caloric prescriptions (described in the Arms section).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the prescribed diet
Time Frame: 12 weeks
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Self-reported caloric intake compared to prescribed caloric intake
|
12 weeks
|
Adherence to the prescribed diet
Time Frame: 12 weeks
|
Evaluated via mathematical model based on change in body mass and composition.
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12 weeks
|
Enrollment Success
Time Frame: 9 months
|
The investigators will assess whether they are able to enroll 24 participants meeting study inclusion/exclusion criteria over a 9-month recruitment window.
If enrollment is <24, the investigators will determine barriers to enrollment and re-evaluate the study design and/or recruitment strategies.
The investigators will also assess participation rate (number approached versus enrolled), reasons potential participants decline enrollment, and ability to meet demographic goals for the larger trial (approximately equal men and women, ≥33% racial and ethnic minorities).
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9 months
|
Attrition Rate
Time Frame: 12 Months
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The investigators will assess the participant drop-out rate and reasons for attrition over the 12-week study, determine reasons for drop-outs and examine whether drop-out rates differ between intervention arms.
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Body Mass
Time Frame: Measured weekly throughout the 12-week trial.
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Measured via calibrated digital scale.
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Measured weekly throughout the 12-week trial.
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Changes in Body Composition
Time Frame: At baseline and post intervention (Week 12).
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Measured via Dual-energy X-ray absorptiometry (DXA) scan
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At baseline and post intervention (Week 12).
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Changes in Resting Energy Expenditure
Time Frame: At baseline and post intervention (Week 12).
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Measured via standard indirect calorimetry with ventilated hood technique
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At baseline and post intervention (Week 12).
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Dietary Adherence
Time Frame: Measured weekly throughout the 12-week trial.
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Evaluated via self-report using a measure created by researchers:
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Measured weekly throughout the 12-week trial.
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Effort
Time Frame: Weekly, throughout the 12-Week Trial
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Measure created by researchers:
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Weekly, throughout the 12-Week Trial
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Self-Efficacy
Time Frame: Weekly, throughout the 12-Week Trial
|
Measure created by researchers:
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Weekly, throughout the 12-Week Trial
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Changes in Food-Related Behaviors
Time Frame: At baseline and post intervention (Week 12).
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Evaluated via Three-Factor Eating Questionnaire, which is divided into three subscales:
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At baseline and post intervention (Week 12).
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Changes in Food-Related Behaviors
Time Frame: At baseline and post intervention (Week 12).
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Evaluated via the Weight Efficacy Lifestyle Questionnaire, which is divided into five subscales:
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At baseline and post intervention (Week 12).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tanya Halliday, PhD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2018
Primary Completion (Actual)
January 25, 2022
Study Completion (Actual)
January 25, 2022
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
June 15, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 15, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-1726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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