Clinical trial NCT05241353: Project THRIVE: Evaluating Different Approaches to Dietary Self-Monitoring for Weight Loss
Official title: A Randomized Pilot Trial of a Tailored, Reduced-Frequency Approach to Dietary Self-Monitoring for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Most lifestyle modification programs for weight loss require comprehensive, precise dietary self-monitoring (DSM) of all food and drink consumed each day. Although theoretically, such approaches should maximize the ability to identify dietary modifications leading to weight loss, the high level of burden associated with these requirements may produce suboptimal weight loss outcomes for many individuals by compromising DSM compliance, accuracy, and utilization for behavior change. A few prior trials have attempted to address this concern by relaxing the standard DSM requirement to record caloric intake precisely. However, such approaches are likely limited in efficacy because they reduce the utility DSM for implementing specific dietary changes. An alternative, as-of-yet untested approach to lower DSM burden would be to require that DSM be performed precisely but with reduced frequency, i.e., only during eating occasions strongly associated with eating patterns that threaten weight control. Thus, the purpose of the current pilot trial will be to compare the standard DSM protocol to a novel, reduced-frequency DSM approach in the context of a 12-week, low-intensity weight loss intervention. Participants (N = 40) will be randomized to receive either standard DSM advice or a reduced-frequency prescription and will receive four remotely-delivered individual coaching calls. The primary aim will be to investigate whether relative to standard DSM, reduced-frequency DSM can yield superior outcomes on four prospective indicators of long-term weight loss success (attitudes, DSM accuracy, utilization of DSM, and sustained compliance with DSM) and also produce comparable weight outcomes by 12 weeks.

All participants will receive a 12-week, low-intensity coaching-based intervention consisting of four individual coaching contacts. All study contacts will occur remotely using the HIPAA-compliant Zoom service at Drexel University. Participants will first complete preliminary eligibility screening via telephone and eligibility will be confirmed during an individual baseline assessment, during which participants will also receive an overview of study procedures. Following the baseline assessment but prior to the first coaching call, participants will engage in fully comprehensive, standard DSM for one week to generate data on the participant's typical dietary patterns, and these data will be used to tailor the DSM prescription in the reduced-frequency DSM group. Participants will also be provided with weekly electronic reading material on principles of behavioral weight control. The first coaching call will be one hour in duration and will provide an overview of general behavioral principles of weight control, including requiring the participant to set specific calorie reduction, self-monitoring and physical activity goals. Participants will also be randomized at during the first coaching call one-to-one fashion to either receive standard DSM advice or to receive a reduced frequency prescription that requires recording only a subset of eating each day throughout the intervention. Permuted block randomization will be performed, stratified on baseline BMI (groups: BMI \<30, BMI 30-35, BMI \>35). Depending on the participant's assignment, he/she/they will be assigned during the baseline coaching call to either continue recording all dietary intake each day (using the Fitbit mobile application) or record a subset of eating tailored to the individual's within-day dietary patterns using a simple algorithm. Subsequent coaching calls will focus on a review of adherence to dietary and physical activity goals and problem-solving solutions to the participant's stated barriers to adherence. Participants in the reduced-frequency group will also have opportunities to modify the self-monitoring prescription during subsequent coaching calls depending on the perceived feasibility of their current prescription. Lastly, participants in both groups will complete a post-treatment assessment during which self-report measures will be completed and skills to maintain after treatment will be reviewed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Baseline Percent Weight Loss at Week 12
timeFrame: Week 0 (Baseline), Week 12 (Post-Treatment)
Secondary outcomes:
measure: Perceived Autonomy Support at Week 12
timeFrame: Week 12 (Post-Treatment)
measure: Change in Weekly Compliance with DSM from Weeks 1 to 12
timeFrame: Week 1 through Week 12 (Post-Treatment)
measure: Change in Week 3 Utilization of Strategies to Ensure DSM Accuracy at Week 12
timeFrame: Week 3, Week 12 (Post-Treatment)
measure: Change in Week 3 Utilization of DSM for Dietary Change at Week 12
timeFrame: Week 3, Week 12 (Post-Treatment)
measure: Change in Baseline Attitudes Towards DSM at Week 12
timeFrame: Week 0 (Baseline), Week 12 (Post-Treatment)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Center for Weight, Eating & Lifestyle Science
state: Pennsylvania
Study officials:
References: