Trial Outcomes & Findings for FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability (NCT NCT03337139)

NCT ID: NCT03337139

Last Updated: 2021-01-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 0, 13, 26, 52 weeks
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	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. 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.	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. 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.
Phase I STARTED	87	0
Phase I COMPLETED	77	0
Phase I NOT COMPLETED	10	0
Phase II STARTED	38	39
Phase II 26 Week Assessment	34	37
Phase II COMPLETED	33	36
Phase II NOT COMPLETED	5	3

Reasons for withdrawal

Measure	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. 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.	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. 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.
Phase I Withdrawal by Subject	10	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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 n=77 Participants Total of all reporting groups
Age, Continuous	51.71 years STANDARD_DEVIATION 13.33 • n=5 Participants	49.84 years STANDARD_DEVIATION 13.56 • n=7 Participants	50.77 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	39 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Change in Body Weight 13 weeks	-5.78 kg Standard Deviation 4.79	-5.80 kg Standard Deviation 4.01
Change in Body Weight 26 weeks	-1.76 kg Standard Deviation 2.81	-1.54 kg Standard Deviation 2.83
Change in Body Weight 52 weeks	1.98 kg Standard Deviation 3.22	0.06 kg Standard Deviation 4.16

PRIMARY outcome

Timeframe: 13, 52 weeks

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

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Change in Physical Activity 13 weeks	173.62 min per week of bouted MVPA Standard Deviation 137.16	125.86 min per week of bouted MVPA Standard Deviation 134.16
Change in Physical Activity 52 weeks	94.15 min per week of bouted MVPA Standard Deviation 99.39	101.68 min per week of bouted MVPA Standard Deviation 98.16

PRIMARY outcome

Timeframe: 26, 52 weeks

Feasibility and acceptability metric of retention.

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Number of Participants Retained 26 weeks	34 Participants	37 Participants
Number of Participants Retained 52 weeks	33 Participants	36 Participants

PRIMARY outcome

Timeframe: 52 weeks

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

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Number of Completed Treatment Contacts Phone Calls	7.37 number completed Standard Deviation 1.55	7.20 number completed Standard Deviation 1.79
Number of Completed Treatment Contacts Text Messages	30.50 number completed Standard Deviation 3.85	29.67 number completed Standard Deviation 5.94

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Treatment Acceptability Questionnaire (TAQ)	65.62 score Standard Deviation 8.43	65.95 score Standard Deviation 7.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Self-monitoring Engagement Weight	43 percent days self-monitoring occurred	58 percent days self-monitoring occurred
Self-monitoring Engagement Eating	41 percent days self-monitoring occurred	67 percent days self-monitoring occurred
Self-monitoring Engagement Physical Activity	79 percent days self-monitoring occurred	80 percent days self-monitoring occurred

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Lifestyle Modification n=38 Participants 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.	Lifestyle Modification + Share n=39 Participants 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.
Perceived Accountability	8.28 unit change Standard Deviation 15.25	6.88 unit change Standard Deviation 16.05

Adverse Events

Lifestyle Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Modification + Share

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lifestyle Modification n=38 participants at risk 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.	Lifestyle Modification + Share n=39 participants at risk 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.
Gastrointestinal disorders Gallstones	0.00% 0/38 • 52 weeks (entire study period)	2.6% 1/39 • Number of events 1 • 52 weeks (entire study period)
Vascular disorders Lightheadedness	0.00% 0/38 • 52 weeks (entire study period)	2.6% 1/39 • Number of events 1 • 52 weeks (entire study period)
Renal and urinary disorders Kidney Stone	0.00% 0/38 • 52 weeks (entire study period)	2.6% 1/39 • Number of events 1 • 52 weeks (entire study period)

Additional Information

Dr. Meghan Butryn

Drexel University

Phone: 215-553-7108

Email: mlb34@drexel.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place