Study of a Personalized vs. Standard Approach to Weight Loss Recommendations

Summary

The purpose of this study is to develop and test the feasibility of a behavioral weight loss intervention that uses personalized recommendations for diet and physical activity behaviors in a behavioral weight loss program and to explore factors associated with treatment adherence and response. The 12-week intervention will utilize digital tools for self-monitoring and counseling by weight management professionals. Exploratory analyses will be conducted to determine if there are genetic, metabolomic, microbiome, or psychosocial factors associated with treatment response.

Conditions

• Overweight and Obesity

Interventions

BEHAVIORAL

Behavioral Weight Loss Program

The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker.

BEHAVIORAL

Personalized Behavioral Weight Loss Program

The PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Deborah F Tate, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-21

Primary Completion

2021-05-10

Completion

2021-05-10

Countries

• United States

Study Locations