FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability

• Sponsor: Drexel University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03337139
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Office of Behavioral and Social Sciences Research (OBSSR) (NIH)
• Enrollment: 87
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight; Overweight and Obesity; Weight Loss	Behavioral: Gold Standard Behavior Therapy for Weight Loss; Behavioral: Standard Remote Behavior Therapy for Weight Loss; Behavioral: Digital Data Sharing Behavior Therapy for Weight Loss	N/A

Detailed Description

In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and physical activity and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small randomized controlled trial in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to-face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, physical activity sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to-face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self-report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, physical activity, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, physical activity, calorie intake, or use of scale, physical activity sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, and 52 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability
• Actual Study Start Date: Nov 17, 2017
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lifestyle Modification Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.	Behavioral: Gold Standard Behavior Therapy for Weight Loss; Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.; Behavioral: Standard Remote Behavior Therapy for Weight Loss; Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.
Experimental: Lifestyle Modification + Share Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.	Behavioral: Gold Standard Behavior Therapy for Weight Loss; Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.; Behavioral: Digital Data Sharing Behavior Therapy for Weight Loss; Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.

Outcome Measures

Primary Outcome Measures

1. Change in Body Weight [0, 13, 26, 52 weeks]

   Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain.

2. Change in Physical Activity [13, 52 weeks]

   Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).

3. Number of Participants Retained [26, 52 weeks]

   Feasibility and acceptability metric of retention.

4. Number of Completed Treatment Contacts [52 weeks]

   Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).

5. Treatment Acceptability Questionnaire (TAQ) [52 weeks]

   Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability.

Secondary Outcome Measures

1. Self-monitoring Engagement [13-52 weeks]

   Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations.

2. Perceived Accountability [52 weeks]

   Change in "Perceptions of Accountability" subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight <160 kg

• Access to a smartphone

• Satisfactory completion of all enrollment procedures

• Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest)

Exclusion Criteria:

• Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may:

• Pose a risk to the participant during the intervention

• Cause a change in weight

• Limit ability to comply with the behavioral recommendations of the program

• Pregnant or planning pregnancy in the next 1 year

• Planned move out of the Philadelphia area during the data collection period

• Use of a pacemaker (incompatible with wireless scale technology)

• Recently began or changed the dosage of a medication that can cause significant change in weight

• History of bariatric surgery

• Weight loss of > 10% in the previous 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drexel University	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Drexel University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Office of Behavioral and Social Sciences Research (OBSSR)

Investigators

• Principal Investigator: Meghan L Butryn, Ph.D., Drexel University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 30, 2020

More Information

Publications

None provided.

• Responsible Party: Meghan Butryn, Principle Investigator, Drexel University
• ClinicalTrials.gov Identifier: NCT03337139
• Other Study ID Numbers: 1611004954; R21DK112741
• First Posted: Nov 8, 2017
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Meghan Butryn, Principle Investigator, Drexel University: Weight Loss; Obesity; Overweight; Behavioral Weight Loss
• Additional relevant MeSH terms: Obesity; Body Weight; Overweight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Period Title: Phase I
STARTED	87	0
COMPLETED	77	0
NOT COMPLETED	10	0
Period Title: Phase I
STARTED	38	39
26 Week Assessment	34	37
COMPLETED	33	36
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share	Total
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.	Total of all reporting groups
Overall Participants	38	39	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.71 (13.33)	49.84 (13.56)	50.77 (13.39)
Sex: Female, Male (Count of Participants)
Female	30 78.9%	32 82.1%	62 80.5%
Male	8 21.1%	7 17.9%	15 19.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.3%	1 2.6%	3 3.9%
Not Hispanic or Latino	36 94.7%	38 97.4%	74 96.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.6%	0 0%	1 1.3%
Asian	2 5.3%	0 0%	2 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 34.2%	15 38.5%	28 36.4%
White	19 50%	22 56.4%	41 53.2%
More than one race	3 7.9%	2 5.1%	5 6.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	38 100%	39 100%	77 100%

Outcome Measures

1. Primary Outcome

Title	Change in Body Weight
Description	Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain.
Time Frame	0, 13, 26, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
13 weeks	-5.78 (4.79)	-5.80 (4.01)
26 weeks	-1.76 (2.81)	-1.54 (2.83)
52 weeks	1.98 (3.22)	0.06 (4.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 13 week weight loss, prior to randomization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.98
	Comments	A priori threshold for statistical significance was p <.05.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 26 week weight loss
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.75
	Comments	A priori threshold for statistical significance was p <.05.
	Method	ANCOVA
	Comments	Controlling for Phase I weight loss

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 52 week weight loss
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for Phase I weight loss

2. Primary Outcome

Title	Change in Physical Activity
Description	Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Time Frame	13, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
13 weeks	173.62 (137.16)	125.86 (134.16)
52 weeks	94.15 (99.39)	101.68 (98.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 13 week MVPA
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.12
	Comments	A priori threshold for statistical significance was p <.05.
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 52 week MVPA
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.16
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for changes in Phase I MVPA

3. Primary Outcome

Title	Number of Participants Retained
Description	Feasibility and acceptability metric of retention.
Time Frame	26, 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
26 weeks	34 89.5%	37 94.9%
52 weeks	33 86.8%	36 92.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 26 week retention rates
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.43
	Comments	A priori threshold for statistical significant was p<.05.
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on 52 week retention rates.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.48
	Comments	A priori threshold for statistical significance was p<.05.
	Method	Fisher Exact
	Comments

4. Primary Outcome

Title	Number of Completed Treatment Contacts
Description	Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
Phone Calls	7.37 (1.55)	7.20 (1.79)
Text Messages	30.50 (3.85)	29.67 (5.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on phone calls completed in Phase II (52 weeks)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.64
	Comments	A priori threshold of statistical significance was p<.05.
	Method	Permutation test
	Comments	Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on text messages completed in Phase II (52 weeks)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.499
	Comments	A priori threshold for statistical significance was p<.05.
	Method	Permutation test
	Comments	Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.

5. Primary Outcome

Title	Treatment Acceptability Questionnaire (TAQ)
Description	Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
Mean (Standard Deviation) [score]	65.62 (8.43)	65.95 (7.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on TAQ scores at 52 weeks
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.86
	Comments	A priori threshold for statistical significance was p<.05.
	Method	Permutation test
	Comments	Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.

6. Secondary Outcome

Title	Self-monitoring Engagement
Description	Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations.
Time Frame	13-52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
Weight	43	58
Eating	41	67
Physical Activity	79	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on percent days of self-monitoring of weight during Phase II
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.002
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for Phase I engagement in self-monitoring

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on percent days of self-monitoring of eating during Phase II
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for Phase I engagement in self-monitoring

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on percent days of self-monitoring of physical activity during Phase II
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.25
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for Phase I engagement in self-monitoring

7. Secondary Outcome

Title	Perceived Accountability
Description	Change in "Perceptions of Accountability" subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Modification	Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
Measure Participants	38	39
Mean (Standard Deviation) [unit change]	8.28 (15.25)	6.88 (16.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Modification, Lifestyle Modification + Share
	Comments	Comparing groups on changes in perceived accountability during Phase II
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments	A priori threshold for statistical significance was p<.05.
	Method	ANCOVA
	Comments	Controlling for Phase I perceived supportive accountability

Adverse Events

Time Frame	52 weeks (entire study period)
Arm/Group Title	Lifestyle Modification		Lifestyle Modification + Share
Arm/Group Description	Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Standard Remote Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.		Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Gold Standard Behavior Therapy for Weight Loss: Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. Digital Data Sharing Behavior Therapy for Weight Loss: Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
All Cause Mortality
	Lifestyle Modification		Lifestyle Modification + Share
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)
Serious Adverse Events
	Lifestyle Modification		Lifestyle Modification + Share
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Lifestyle Modification		Lifestyle Modification + Share
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		3/39 (7.7%)
Gastrointestinal disorders
Gallstones	0/38 (0%)	0	1/39 (2.6%)	1
Renal and urinary disorders
Kidney Stone	0/38 (0%)	0	1/39 (2.6%)	1
Vascular disorders
Lightheadedness	0/38 (0%)	0	1/39 (2.6%)	1

Limitations/Caveats

Low proportion of men and adults over age 70 limits generalizability; calls and texts were not qualitatively analyzed nor rated for treatment fidelity; length of each telephone session was not measured; it is unknown to what extent participants shared device data with friends/family/other participants and threatened contamination; low power.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.