Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss
- Conditions
- OverweightObesity
- Interventions
- Behavioral: Coach Share OnBehavioral: Group Share OnBehavioral: Coach Share OffBehavioral: Friend/Family Share OnBehavioral: Friend/Family Share OffBehavioral: Group Share OffBehavioral: Behavioral Weight Loss Treatment
- Registration Number
- NCT05180448
- Lead Sponsor
- Drexel University
- Brief Summary
Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis.
- Detailed Description
Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis. Groups will meet remotely each week in months 1-3 to initiate weight loss. In months 4-24, intervention contact will be remote and will include the following: quarterly group meetings held via videoconference; brief phone calls with the coach held twice per quarter; and monthly text messages with the coach, with a small group of fellow group participants, and with a friend or family member outside of the program. Text message content will vary according to treatment condition, i.e. three types of data sharing partnerships: Coach Share, Group Share, and Friend/Family Share. Outcomes will be measured at months 0, 3, 6, 12, and 24. Primary aims include determining if Coach Share, Group Share, and Friend/ Family Share each improve long-term weight loss, PA, and calorie intake, and examining if effects are additive when participants are assigned to engage in more than one type of data sharing partnership. The secondary aim is to explore mediators and moderators of intervention effects. The tertiary aim is to determine how the quality of relationship with coach, group members, and friends/family member over time may differentially moderate treatment effects and predict data sharing efficacy. As digital technology makes data sharing increasingly feasible, it is critical to determine how to optimize these partnerships to improve long-term outcomes in LM.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- Individuals must be of overweight or obese BMI (27-50 kg/m2)
- Individuals must be adults (aged 18-70)
- Able to engage in physical activity (defined as walking two city blocks without stopping)
- Access and willingness to use a smartphone and internet
- Has one adult friend or family member who indicates willingness to serve in a support role
- Satisfactory completion of all enrollment procedures
- English Speaking
- Medical or psychiatric condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight, or limit ability to comply with the program or participate appropriately in group-based treatment
- Currently pregnant or breastfeeding, or planning to become pregnant in the next 24 months
- Use of insulin or a medication that can cause significant change in weight
- History of bariatric surgery
- Weight loss of greater than or equal to 5% in the previous 3 months
- Weight loss of greater than or equal to 10% in the past 3 years that is currently being maintained
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Coach Share On + Group Share Off + Group Share Off Behavioral Weight Loss Treatment - Coach Share On + Group Share On + Friend/Family Share On Friend/Family Share On - Coach Share On + Group Share On + Friend/Family Share On Behavioral Weight Loss Treatment - Coach Share On + Group Share On + Friend/Family Share On Group Share On - Coach Share On + Group Share On + Friend/Family Share Off Group Share On - Coach Share On + Group Share On + Friend/Family Share Off Friend/Family Share Off - Coach Share On + Group Share On + Friend/Family Share On Coach Share On - Coach Share On + Group Share On + Friend/Family Share Off Coach Share On - Coach Share On + Group Share On + Friend/Family Share Off Behavioral Weight Loss Treatment - Coach Share On + Group Share Off + Friend/Family Share On Coach Share On - Coach Share On + Group Share Off + Friend/Family Share On Friend/Family Share On - Coach Share On + Group Share Off + Friend/Family Share On Behavioral Weight Loss Treatment - Coach Share Off + Group Share Off + Friend/Family Share On Friend/Family Share On - Coach Share Off + Group Share Off + Friend/Family Share Off Behavioral Weight Loss Treatment - Coach Share On + Group Share Off + Friend/Family Share On Group Share Off - Coach Share On + Group Share Off + Group Share Off Group Share Off - Coach Share Off + Group Share On + Friend/Family Share On Group Share On - Coach Share Off + Group Share On + Friend/Family Share On Behavioral Weight Loss Treatment - Coach Share Off + Group Share On + Friend/Family Share Off Friend/Family Share Off - Coach Share Off + Group Share Off + Friend/Family Share On Coach Share Off - Coach Share Off + Group Share Off + Friend/Family Share Off Friend/Family Share Off - Coach Share On + Group Share Off + Group Share Off Coach Share On - Coach Share Off + Group Share Off + Friend/Family Share On Group Share Off - Coach Share Off + Group Share Off + Friend/Family Share Off Coach Share Off - Coach Share Off + Group Share On + Friend/Family Share Off Behavioral Weight Loss Treatment - Coach Share Off + Group Share Off + Friend/Family Share On Behavioral Weight Loss Treatment - Coach Share On + Group Share Off + Group Share Off Friend/Family Share Off - Coach Share Off + Group Share On + Friend/Family Share On Friend/Family Share On - Coach Share Off + Group Share On + Friend/Family Share On Coach Share Off - Coach Share Off + Group Share On + Friend/Family Share Off Group Share On - Coach Share Off + Group Share On + Friend/Family Share Off Coach Share Off - Coach Share Off + Group Share Off + Friend/Family Share Off Group Share Off -
- Primary Outcome Measures
Name Time Method Weight 0 month, 3 month, 6 month, 12 month, 24 month Weight will be measured using a wireless scale. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) remove errant weights (e.g., \>1 kg change in 1 day).
- Secondary Outcome Measures
Name Time Method Calorie Intake 0 month, 3 month, 6 month, 12 month, 24 month Average calorie intake over 7 days will be derived from the Fitbit digital food log as a secondary outcome.
Physical Activity 0 month, 3 month, 6 month, 12 month, 24 month Minutes per week of moderate-to-vigorous PA will be measured by using FitBit. Steps per day from the Fitbit also will be examined.
Trial Locations
- Locations (1)
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States