Project THRIVE: Evaluating Different Approaches to Dietary Self-Monitoring for Weight Loss

NCT05241353 | Completed

• 1 other identifier: PROJECTTHRIVE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot trial will compare two approaches to dietary self-monitoring for weight loss in the context of a low-intensity, remotely-delivered lifestyle modification program. Participants (N=40) will be randomized to perform detailed self-monitoring of all food and drink consumed each day or a reduced frequency, partial prescription involving recording only a subset of daily intake. The investigators will compare differences in weight loss as well as on relevant mechanistic, behavioral outcomes between groups at 12 weeks.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Change in Baseline Percent Weight Loss at Week 12

  Weight will be assessed at baseline and weekly throughout the intervention. Participants will be instructed to self-weigh on one consistent morning per week before 11am, following specific instructions (i.e., wear light clothing, keep scale on a flat surface, weigh before eating or drinking) and then self-report weight using the Fitbit app where it can be later exported by research staff. Participants will be required to self-weigh using a reliable, digital wireless scale that can estimate weight to the nearest tenth of a pound. Percent weight loss at week 12 will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.

  Week 0 (Baseline), Week 12 (Post-Treatment)

Secondary Outcomes (5)

• Perceived Autonomy Support at Week 12

  Week 12 (Post-Treatment)

• Change in Weekly Compliance with DSM from Weeks 1 to 12

  Week 1 through Week 12 (Post-Treatment)

• Change in Week 3 Utilization of Strategies to Ensure DSM Accuracy at Week 12

  Week 3, Week 12 (Post-Treatment)

• Change in Week 3 Utilization of DSM for Dietary Change at Week 12

  Week 3, Week 12 (Post-Treatment)

• Change in Baseline Attitudes Towards DSM at Week 12

  Week 0 (Baseline), Week 12 (Post-Treatment)

Study Arms (2)

Standard Self-Monitoring Group

ACTIVE COMPARATOR

Standard behavioral treatment with a standard (full-frequency) self-monitoring prescription.

Behavioral: Full-Frequency Self-Monitoring; Behavioral: Standard Behavioral Treatment

Reduced-Frequency Group

EXPERIMENTAL

Standard behavioral treatment with a reduced-frequency self-monitoring prescription.

Behavioral: Reduced Frequency Self-Monitoring; Behavioral: Standard Behavioral Treatment

Interventions

Reduced Frequency Self-Monitoring BEHAVIORAL

Participants will be asked to record only a subset of daily eating throughout the intervention, with the prescription for self-monitoring individually tailored at baseline dependent on participants' self-reported eating patterns.

Reduced-Frequency Group

Full-Frequency Self-Monitoring BEHAVIORAL

Participants will be asked to record all contents of their diet throughout the intervention.

Standard Self-Monitoring Group

Standard Behavioral Treatment BEHAVIORAL

Participants will receive four individual coaching calls over 12 weeks. During coaching calls, participants will receive guidance on lowering calorie intake, increasing physical activity and use of specific behavioral strategies to increase the probability of success with weight loss.

Reduced-Frequency Group; Standard Self-Monitoring Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old
• Currently living in the United States
• Current body mass index (BMI) of 25-50 kg/m2, with individuals with BMI \> 50 excluded due to the higher risk of medical complications
• Access to a regular internet connection
• Ability to understand and provide informed consent
• Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
• Proficiency in speaking, reading, and writing English
• Ability to engage in physical activity, defined as the ability to walk at least the length of two city blocks without stopping
• Access to or willing to purchase a digital wireless body weight scale

You may not qualify if:

• Present involvement in another lifestyle modification or obesity treatment program
• Currently breastfeeding, pregnant or planning to become pregnant within 4 months from the time of screening
• Having lost more than 5% of body weight in the past 3 months
• History of bariatric surgery
• Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were made in past 2 years)
• Self-reported diagnosis of a medical or psychiatric condition that could make standard behavioral weight loss treatment contraindicated, including: insulin-dependent diabetes (type 1 or type 2; individuals with diabetes who do not take insulin will not be excluded), cancer, loss-of-control eating (three or more times in the past month), inappropriate compensatory behaviors to control weight (vomiting, misuse of laxatives or diuretics, or compelled exercise) in the past month, current unmedicated bipolar or psychotic disorder, or current psychiatric symptoms that would interfere with an individual's ability to complete the program.
• Technological or interpersonal difficulties contraindicating participation in a remotely delivered coaching program

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University Center for Weight, Eating & Lifestyle Science

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be concealed from outcome assessors. The allocation sequence will also be blinded in advance from individuals involved in the randomization process. However, it will not be fully possible to blind participants due to the nature of the trial (i.e., assignments will be evident to participants).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two arms (standard versus reduced-frequency). Participants will be assigned in a one-to-one fashion at baseline to one of the two groups.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: April 25, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)