Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Coach Share On
* Behavioral: Group Share On
* Behavioral: Friend/Family Share On
* Behavioral: Coach Share Off
* Behavioral: Group Share Off
* Behavioral: Friend/Family Share Off
* Behavioral: Behavioral Weight Loss Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This is a 2x2x2 design. There are three factors, each with two levels: ON vs OFF
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coach Share On + Group Share On + Friend/Family Share On<br> | Behavioral: Coach Share On<br>* If an index participant is randomized to have Coach Share ON, the coach will have continuous access to objective, real-time, detailed device data, and address data directly in all individual interactions with index participants (groups, individual weigh-ins, phone calls, texts), conveying that they are closely monitoring progress.<br>Behavioral: Group Share On<br>* If Group Share is ON, participants in a given LM group will view and respond to aspects of each other's self-monitoring device data in their small-group text messages. Each small group participant's data will be highlighted one day of the month, and content from the Group Share Off message library also will be sent.<br>Behavioral: Friend/Family Share On<br>* Index participants who are randomized to have Friend/Family Share ON will give their friend or family member access to their self-monitoring data. Text messages sent by the program bot, which includes the index participant and friend/family member, will use a similar format as described in Group Share ON. The friend or family member will be trained to respond to data in ways that enhance the participant's motivation and self-regulation.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share On + Group Share On + Friend/Family Share Off<br> | Behavioral: Coach Share On<br>* If an index participant is randomized to have Coach Share ON, the coach will have continuous access to objective, real-time, detailed device data, and address data directly in all individual interactions with index participants (groups, individual weigh-ins, phone calls, texts), conveying that they are closely monitoring progress.<br>Behavioral: Group Share On<br>* If Group Share is ON, participants in a given LM group will view and respond to aspects of each other's self-monitoring device data in their small-group text messages. Each small group participant's data will be highlighted one day of the month, and content from the Group Share Off message library also will be sent.<br>Behavioral: Friend/Family Share Off<br>* If an index participant is randomized to Friend/Family Share OFF, the text messages from the bot will prompt the participant and friend/family member to communicate about the LM program; those messages will be standardized, except for names, and will not be tailored to index participant progress. Index participants will be instructed to refrain from sharing any device data with friends or family members.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share On + Group Share Off + Friend/Family Share On<br> | Behavioral: Coach Share On<br>* If an index participant is randomized to have Coach Share ON, the coach will have continuous access to objective, real-time, detailed device data, and address data directly in all individual interactions with index participants (groups, individual weigh-ins, phone calls, texts), conveying that they are closely monitoring progress.<br>Behavioral: Friend/Family Share On<br>* Index participants who are randomized to have Friend/Family Share ON will give their friend or family member access to their self-monitoring data. Text messages sent by the program bot, which includes the index participant and friend/family member, will use a similar format as described in Group Share ON. The friend or family member will be trained to respond to data in ways that enhance the participant's motivation and self-regulation.<br>Behavioral: Group Share Off<br>* Among index participants randomized to have Group Share OFF, supportive accountability will not be the target of participant interactions and no data will be shared with LM program peers. Instead, once weekly prompts for small group text exchanges will encourage index participants to provide social support (primarily of the informational type) to each other. Index participants will be explicitly told that they should not include information on goal progress such as weight change or minutes of PA.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share On + Group Share Off + Group Share Off<br> | Behavioral: Coach Share On<br>* If an index participant is randomized to have Coach Share ON, the coach will have continuous access to objective, real-time, detailed device data, and address data directly in all individual interactions with index participants (groups, individual weigh-ins, phone calls, texts), conveying that they are closely monitoring progress.<br>Behavioral: Group Share Off<br>* Among index participants randomized to have Group Share OFF, supportive accountability will not be the target of participant interactions and no data will be shared with LM program peers. Instead, once weekly prompts for small group text exchanges will encourage index participants to provide social support (primarily of the informational type) to each other. Index participants will be explicitly told that they should not include information on goal progress such as weight change or minutes of PA.<br>Behavioral: Friend/Family Share Off<br>* If an index participant is randomized to Friend/Family Share OFF, the text messages from the bot will prompt the participant and friend/family member to communicate about the LM program; those messages will be standardized, except for names, and will not be tailored to index participant progress. Index participants will be instructed to refrain from sharing any device data with friends or family members.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share Off + Group Share On + Friend/Family Share On<br> | Behavioral: Group Share On<br>* If Group Share is ON, participants in a given LM group will view and respond to aspects of each other's self-monitoring device data in their small-group text messages. Each small group participant's data will be highlighted one day of the month, and content from the Group Share Off message library also will be sent.<br>Behavioral: Friend/Family Share On<br>* Index participants who are randomized to have Friend/Family Share ON will give their friend or family member access to their self-monitoring data. Text messages sent by the program bot, which includes the index participant and friend/family member, will use a similar format as described in Group Share ON. The friend or family member will be trained to respond to data in ways that enhance the participant's motivation and self-regulation.<br>Behavioral: Coach Share Off<br>* Among index participants who are randomized to have Coach Share OFF, the coach will have no access to their device data. Index participants will be explicitly told their coach does not have data access. During groups and phone calls, the participant will self-report progress, and goal setting will be based on that self-report. Text messages from the coach will be personalized in the OFF condition, as they are when coach data sharing is ON, though these messages will not be informed by device data. Instead, text messages will provide a reminder of key goals and strategies discussed in the previous phone call and provide encouragement for participant efforts.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share Off + Group Share On + Friend/Family Share Off<br> | Behavioral: Group Share On<br>* If Group Share is ON, participants in a given LM group will view and respond to aspects of each other's self-monitoring device data in their small-group text messages. Each small group participant's data will be highlighted one day of the month, and content from the Group Share Off message library also will be sent.<br>Behavioral: Coach Share Off<br>* Among index participants who are randomized to have Coach Share OFF, the coach will have no access to their device data. Index participants will be explicitly told their coach does not have data access. During groups and phone calls, the participant will self-report progress, and goal setting will be based on that self-report. Text messages from the coach will be personalized in the OFF condition, as they are when coach data sharing is ON, though these messages will not be informed by device data. Instead, text messages will provide a reminder of key goals and strategies discussed in the previous phone call and provide encouragement for participant efforts.<br>Behavioral: Friend/Family Share Off<br>* If an index participant is randomized to Friend/Family Share OFF, the text messages from the bot will prompt the participant and friend/family member to communicate about the LM program; those messages will be standardized, except for names, and will not be tailored to index participant progress. Index participants will be instructed to refrain from sharing any device data with friends or family members.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share Off + Group Share Off + Friend/Family Share On<br> | Behavioral: Friend/Family Share On<br>* Index participants who are randomized to have Friend/Family Share ON will give their friend or family member access to their self-monitoring data. Text messages sent by the program bot, which includes the index participant and friend/family member, will use a similar format as described in Group Share ON. The friend or family member will be trained to respond to data in ways that enhance the participant's motivation and self-regulation.<br>Behavioral: Coach Share Off<br>* Among index participants who are randomized to have Coach Share OFF, the coach will have no access to their device data. Index participants will be explicitly told their coach does not have data access. During groups and phone calls, the participant will self-report progress, and goal setting will be based on that self-report. Text messages from the coach will be personalized in the OFF condition, as they are when coach data sharing is ON, though these messages will not be informed by device data. Instead, text messages will provide a reminder of key goals and strategies discussed in the previous phone call and provide encouragement for participant efforts.<br>Behavioral: Group Share Off<br>* Among index participants randomized to have Group Share OFF, supportive accountability will not be the target of participant interactions and no data will be shared with LM program peers. Instead, once weekly prompts for small group text exchanges will encourage index participants to provide social support (primarily of the informational type) to each other. Index participants will be explicitly told that they should not include information on goal progress such as weight change or minutes of PA.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|
| Experimental: Coach Share Off + Group Share Off + Friend/Family Share Off<br> | Behavioral: Coach Share Off<br>* Among index participants who are randomized to have Coach Share OFF, the coach will have no access to their device data. Index participants will be explicitly told their coach does not have data access. During groups and phone calls, the participant will self-report progress, and goal setting will be based on that self-report. Text messages from the coach will be personalized in the OFF condition, as they are when coach data sharing is ON, though these messages will not be informed by device data. Instead, text messages will provide a reminder of key goals and strategies discussed in the previous phone call and provide encouragement for participant efforts.<br>Behavioral: Group Share Off<br>* Among index participants randomized to have Group Share OFF, supportive accountability will not be the target of participant interactions and no data will be shared with LM program peers. Instead, once weekly prompts for small group text exchanges will encourage index participants to provide social support (primarily of the informational type) to each other. Index participants will be explicitly told that they should not include information on goal progress such as weight change or minutes of PA.<br>Behavioral: Friend/Family Share Off<br>* If an index participant is randomized to Friend/Family Share OFF, the text messages from the bot will prompt the participant and friend/family member to communicate about the LM program; those messages will be standardized, except for names, and will not be tailored to index participant progress. Index participants will be instructed to refrain from sharing any device data with friends or family members.<br>Behavioral: Behavioral Weight Loss Treatment<br>* Standard Behavioral Weight Loss Treatment (remotely delivered)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | 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). | 0 month, 3 month, 6 month, 12 month, 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Minutes per week of moderate-to-vigorous PA will be measured by using FitBit. Steps per day from the Fitbit also will be examined. | 0 month, 3 month, 6 month, 12 month, 24 month | 
| Calorie Intake | Average calorie intake over 7 days will be derived from the Fitbit digital food log as a secondary outcome. | 0 month, 3 month, 6 month, 12 month, 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, lifestyle modification, behavioral modification, overweight, obesity