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

NCT03560635 | Completed

• 1 other identifier: 17-1726
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Overweight and Obesity; Weight Loss Maintenance; Dietary Habits

Keywords

weight loss maintenance; reverse diet; body composition; metabolic rate; dietary adherence; resting energy expenditure; weight loss; weight regain

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Changes in Body Mass

  Measured weekly throughout the 12-week trial.

• Changes in Body Composition

  At baseline and post intervention (Week 12).

• Changes in Resting Energy Expenditure

  At baseline and post intervention (Week 12).

• Dietary Adherence

  Measured weekly throughout the 12-week trial.

• Effort

  Weekly, throughout the 12-Week Trial

Study Arms (2)

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.

Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet)

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.

Behavioral: Weight Loss Maintenance (Control vs. Reverse Diet)

Interventions

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).

Control; Reverse Diet

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Denver, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Feeding Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Body Weight Changes

Study Officials

• Tanya Halliday, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 18, 2018
• Study Start: February 14, 2018
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)