Clinical Trials Directory

Trials / Completed

CompletedNCT03560635

Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
21 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeight Loss Maintenance (Control vs. Reverse Diet)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).

Timeline

Start date
2018-02-14
Primary completion
2022-01-25
Completion
2022-01-25
First posted
2018-06-18
Last updated
2022-04-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03560635. Inclusion in this directory is not an endorsement.