University of Denver, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
NCT Number: NCT03560635
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.
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Notify Me21 year–70 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 12 weeks
Self-reported caloric intake compared to prescribed caloric intake
Time frame: 12 weeks
Evaluated via mathematical model based on change in body mass and composition.
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).
Time frame: 12 Months
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.
Time frame: Measured weekly throughout the 12-week trial.
Measured via calibrated digital scale.
Time frame: At baseline and post intervention (Week 12).
Measured via Dual-energy X-ray absorptiometry (DXA) scan
Time frame: At baseline and post intervention (Week 12).
Measured via standard indirect calorimetry with ventilated hood technique
Time frame: Measured weekly throughout the 12-week trial.
Evaluated via self-report using a measure created by researchers:
Time frame: Weekly, throughout the 12-Week Trial
Measure created by researchers:
Time frame: Weekly, throughout the 12-Week Trial
Measure created by researchers:
Time frame: At baseline and post intervention (Week 12).
Evaluated via Three-Factor Eating Questionnaire, which is divided into three subscales:
Time frame: At baseline and post intervention (Week 12).
Evaluated via the Weight Efficacy Lifestyle Questionnaire, which is divided into five subscales:
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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