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

NCT04639076 | Completed

• 1 other identifier: 19-2003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in weight (kg)

  Weight will be measured in kg on a calibrated digital scale. Greater negative changes in weight from baseline to 3 months indicate greater weight loss and better outcome.

  Baseline, Month 3

Secondary Outcomes (6)

• Change in Body Mass Index (BMI)

  Baseline, Month 3

• Change in Visual Analog Score (VAS) for hunger and fullness

  Baseline, Month 3

• Change in dietary intake (total kcals)

  Baseline, Month 3

• Change in dietary intake (percent kcals from carbohydrate, fat, and protein)

  Baseline, Month 3

• Change in weekly energy expenditure in kcals

  Baseline, Month 3

Study Arms (2)

Behavioral Weight Loss Group

ACTIVE COMPARATOR

Participants in this arm will receive a standard behavioral weight loss approach that recommends a calorie deficit based on starting weight, a standard activity minute goal progression based on baseline activity and standard behavioral weekly counseling.

Behavioral: Behavioral Weight Loss Program

Personalized Behavioral Weight Loss Group

EXPERIMENTAL

Participants in this arm will receive a personalized weight loss approach that recommends either a low carbohydrate or low fat calorie reduced diet; personalized activity plan with either daily or weekly bout-related goals; and eating frequency of either 3 times per day or 5-6 times per day.

Behavioral: Personalized Behavioral Weight Loss Program

Interventions

Behavioral Weight Loss Program BEHAVIORAL

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 Weight Loss Group

Personalized Behavioral Weight Loss Program BEHAVIORAL

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.

Personalized Behavioral Weight Loss Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 25-50 kg/m\^2
• Normal or impaired glucose as determined by HbA1c fingerstick (\<6.5%)
• Own an iPhone with a data and text messaging plan
• Have home Wi-Fi access
• Have the ability to read, write, and speak English
• Not meeting the American College of Sports Medicine recommendation of 150 minutes of Moderate to Vigorous Physical Activity each week
• Ability to attend 2 in-person assessment visits at the University of North Carolina (UNC) Weight Research Program clinic (at baseline and follow-up) and participate in 12 weekly remote visits with a study interventionist via phone or video call over the 12 week intervention
• Can obtain primary care provider consent that participation is appropriate if needed

You may not qualify if:

• Lost more than 10 pounds in the last 6 months and kept it off
• History of weight loss surgery
• Currently participating in another physical activity or weight loss program or research study that may interfere with participation in this study
• Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 4 months
• Planning to relocate in the next 4 months
• Cannot attend 2 in-person assessment visits at the UNC Weight Research Program clinic (at baseline and follow-up) and participate in 12 weekly remote visits with a study interventionist via phone or video call over the 12 week intervention
• Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the Physical Activity Readiness Questionnaire (PAR-Q)
• Diagnosis of diabetes
• Taking medications to treat prediabetes
• Report taking prescription or over the counter medication with a known impact on metabolism or weight
• Current treatment for cancer
• History of clinically diagnosed eating disorder
• Diagnosis of schizophrenia or bipolar disorder
• Hospitalization for a psychiatric diagnosis within the last year

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Martinez CE, Hatley KE, Polzien K, Diamond M, Tate DF. Testing a Personalized Behavioral Weight Loss Approach Using Multifactor Prescriptions and Self-Experimentation: 12-Week mHealth Pilot Randomized Controlled Trial Results. Obes Sci Pract. 2025 Feb 4;11(1):e70051. doi: 10.1002/osp4.70051. eCollection 2025 Feb.

  PMID: 39911449 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Deborah F Tate, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: October 21, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: October 7, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)