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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| Reverse Diet | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss Maintenance (Control vs. Reverse Diet) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the prescribed diet | Self-reported caloric intake compared to prescribed caloric intake | 12 weeks |
| Adherence to the prescribed diet | Evaluated via mathematical model based on change in body mass and composition. | 12 weeks |
| Enrollment Success | 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). | 9 months |
| Attrition Rate | 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Mass | Measured via calibrated digital scale. | Measured weekly throughout the 12-week trial. |
| Changes in Body Composition | Measured via Dual-energy X-ray absorptiometry (DXA) scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Halliday, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Denver, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| At baseline and post intervention (Week 12). |
| Changes in Resting Energy Expenditure | Measured via standard indirect calorimetry with ventilated hood technique | At baseline and post intervention (Week 12). |
| Dietary Adherence | Evaluated via self-report using a measure created by researchers:
| Measured weekly throughout the 12-week trial. |
| Effort | Measure created by researchers:
| Weekly, throughout the 12-Week Trial |
| Self-Efficacy | Measure created by researchers:
| Weekly, throughout the 12-Week Trial |
| Changes in Food-Related Behaviors | Evaluated via Three-Factor Eating Questionnaire, which is divided into three subscales:
| At baseline and post intervention (Week 12). |
| Changes in Food-Related Behaviors | Evaluated via the Weight Efficacy Lifestyle Questionnaire, which is divided into five subscales:
| At baseline and post intervention (Week 12). |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
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