Clinical trial NCT05180448: Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss
Official title: Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Obesity
Keywords: weight loss
lifestyle modification
behavioral modification
overweight
obesity
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2x2x2 design. There are three factors, each with two levels: ON vs OFF
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight
timeFrame: 0 month, 3 month, 6 month, 12 month, 24 month
Secondary outcomes:
measure: Physical Activity
timeFrame: 0 month, 3 month, 6 month, 12 month, 24 month
measure: Calorie Intake
timeFrame: 0 month, 3 month, 6 month, 12 month, 24 month
Other outcomes:
measure: Perceived Supportive Accountability for Weight Control
timeFrame: 0 months, 6 month, 12 month, 24 month
measure: Self-regulation value of program components
timeFrame: 3 months, 6 month, 12 month, 24 month
measure: Self-monitoring
timeFrame: Calculated continuously for 24 months
measure: social comparison
timeFrame: 0, 12, 24 months
measure: Perceived Social Support
timeFrame: 0 months, 6 month, 12 month, 24 month
measure: Relationship Quality
timeFrame: 0, 3, 6, 12, 24 months
measure: Weight Self-Stigma
timeFrame: 0 months
measure: Friend/family characteristics
timeFrame: 0, 3, 6, 12, 24 months
measure: Small group dynamic
timeFrame: 3, 6, 12, 24 months
measure: Demographic variables
timeFrame: 0 months
measure: Coach characteristics
timeFrame: 0 months
measure: Method of message delivery
timeFrame: 0 months
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Meghan L Butryn, PhD
role: PRINCIPAL_INVESTIGATOR
References: