Trial Outcomes & Findings for Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care (NCT NCT03003403)

Last Updated: 2025-04-16

Results Overview

The proportion of intervention arm participants who achieve weight again prevention (staying within 3% of baseline weight in kg) at 24 months post-randomization. This will be calculated as follows: ((baseline weight in kg - final weight at 24 months in kg)/baseline weight in kg))x 100

Recruitment status

COMPLETED

Study phase

Target enrollment

443 participants

Primary outcome timeframe

Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Results posted on

2025-04-16

Participant Flow

Patients were recruited from partnering community health centers (CHCs) that worked with the Duke research team. Per privacy regulations, prior to being contacted by a team member, CHC patients were asked to review/sign a HIPAA authorization form to give permission to be contacted for recruitment. Once the form was received, study team members conducted an eligibility review in the CHC EHR. If eligible and interested, additional screening, verbal consent and randomization occurred via phone.

443 participants were randomized after being eligible upon EHR chart review; phone screen and verbal consent and randomization.

Participant milestones

Participant milestones
Measure	Intervention Program Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Overall Study STARTED	223	220
Overall Study COMPLETED	212	212
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Program Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Overall Study Ineligible	8	7
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Program n=223 Participants Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 Participants Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.	Total n=443 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 13.6 • n=39 Participants	46.8 years STANDARD_DEVIATION 13.0 • n=41 Participants	47.6 years STANDARD_DEVIATION 13.3 • n=35 Participants
Sex/Gender, Customized Male	43 Participants n=39 Participants	46 Participants n=41 Participants	89 Participants n=35 Participants
Sex/Gender, Customized Female	179 Participants n=39 Participants	173 Participants n=41 Participants	352 Participants n=35 Participants
Sex/Gender, Customized Male to Female Transgender	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Race/Ethnicity, Customized Hispanic (all races)	102 Participants n=39 Participants	98 Participants n=41 Participants	200 Participants n=35 Participants
Race/Ethnicity, Customized Non-Hispanic White	61 Participants n=39 Participants	54 Participants n=41 Participants	115 Participants n=35 Participants
Race/Ethnicity, Customized Non-Hispanic Black	53 Participants n=39 Participants	53 Participants n=41 Participants	106 Participants n=35 Participants
Race/Ethnicity, Customized Non-Hispanic other/unreported	7 Participants n=39 Participants	15 Participants n=41 Participants	22 Participants n=35 Participants
BMI	32.4 kg/m2 STANDARD_DEVIATION 4.0 • n=39 Participants	32.9 kg/m2 STANDARD_DEVIATION 3.9 • n=41 Participants	32.6 kg/m2 STANDARD_DEVIATION 4.0 • n=35 Participants

PRIMARY outcome

Timeframe: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Population: Entire sample analyzed for primary endpoint at 24-months

Outcome measures

Outcome measures
Measure	Intervention Program n=223 Participants Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 Participants Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Change in Weight at 24-months Gained more than 3%	28 Participants	29 Participants
Change in Weight at 24-months Gained less than or equal to 3% of predicted baseline weight	88 Participants	90 Participants
Change in Weight at 24-months Not measured in time window	107 Participants	101 Participants

SECONDARY outcome

Timeframe: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Population: Average weight change (kg) at 24 months.

Average change in participant weight at 24 months post randomization, as measured in kg

Outcome measures

Outcome measures
Measure	Intervention Program n=223 Participants Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 Participants Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Change in Weight	0.4 change in weight by kg Interval -0.4 to 1.2	0.5 change in weight by kg Interval -0.3 to 1.5

SECONDARY outcome

Timeframe: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Population: Predicted mean change (in mmHg) in systolic blood pressure and diastolic blood pressure, from baseline to 24 months, by study arm

Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg), by arm

Outcome measures

Outcome measures
Measure	Intervention Program n=223 Participants Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 Participants Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Change in Blood Pressure Average change in systolic blood pressure	-1.3 millimeters of mercury (mmHg) Interval -3.1 to 0.6	-0.1 millimeters of mercury (mmHg) Interval -2.0 to 1.9
Change in Blood Pressure Average change in diastolic blood pressure	-2.8 millimeters of mercury (mmHg) Interval -4.0 to -1.5	-2 millimeters of mercury (mmHg) Interval -3.3 to -0.7

SECONDARY outcome

Timeframe: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Population: Calculated mean change in 10-year cardiovascular risk between baseline and 24-months post-randomization by treatment arm.

Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study. The Framingham Risk Score provides an estimate of the 10-year risk of developing cardiovascular disease. A decrease (negative) in score indicated a decreased 10-year risk of developing cardiovascular disease; an increase (positive) in score meant an increased 10-year risk of developing cardiovascular disease. Framingham score ranges vary by gender. For men, the minimum score is: -10 and maximum score is 21. For women: the min score is -8 and max score is 27.

Outcome measures

Outcome measures
Measure	Intervention Program n=223 Participants Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 Participants Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Change in Framingham Risk Score	-0.01 units on a scale Interval -0.6 to 0.6	-0.01 units on a scale Interval -0.7 to 0.6

Adverse Events

Intervention Program

Serious events: 22 serious events

Other events: 42 other events

Deaths: 0 deaths

Usual Care Program

Serious events: 13 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Program n=223 participants at risk Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 participants at risk Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Gastrointestinal disorders Severe abdominal pain, discomfort, symptoms	1.3% 3/223 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.91% 2/220 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Injury, poisoning and procedural complications Motor vehicle accident; fall	1.3% 3/223 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Musculoskeletal and connective tissue disorders Bone fracture	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cysts/Polyps requiring cancer treatment/other intervention	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Nervous system disorders Parkinson's related complications	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.91% 2/220 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Respiratory, thoracic and mediastinal disorders Breathing complications (asthma, COVID19, infections)	1.8% 4/223 • Number of events 4 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	1.4% 3/220 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Surgical and medical procedures Surgical procedures for heart/GI	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Psychiatric disorders Psychosis	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Endocrine disorders Diabetes related complications	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Renal and urinary disorders Kidney and urinary tract infection	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Cardiac disorders Hypertension-related complications	2.2% 5/223 • Number of events 5 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	1.8% 4/220 • Number of events 4 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Skin and subcutaneous tissue disorders Skin infections	0.00% 0/223 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.91% 2/220 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Infections and infestations General infectious diseases	0.90% 2/223 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.

Other adverse events

Additional Information

Gary G. Bennett, PhD

Duke University

Phone: 919-808-7821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention Program n=223 participants at risk Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dietitians serving as health coaches within a local network of community health centers. Intervention Program: Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.	Usual Care Program n=220 participants at risk Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Cardiac disorders Hypertension-related issues	2.2% 5/223 • Number of events 5 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	2.3% 5/220 • Number of events 5 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Injury, poisoning and procedural complications Minor falls	4.9% 11/223 • Number of events 11 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	1.8% 4/220 • Number of events 4 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Eye disorders Eye infections	1.3% 3/223 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Renal and urinary disorders Minor UTIs	1.8% 4/223 • Number of events 5 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Gastrointestinal disorders Minor stomach pain	1.8% 4/223 • Number of events 7 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	3.2% 7/220 • Number of events 7 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Musculoskeletal and connective tissue disorders Sprains/strains	1.8% 4/223 • Number of events 6 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	1.8% 4/220 • Number of events 10 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Nervous system disorders Minor nerve pain/issues	0.45% 1/223 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms/cysts	0.00% 0/223 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	1.4% 3/220 • Number of events 4 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Psychiatric disorders Psychiatric condition (due to lack of medication)	0.00% 0/223 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Respiratory, thoracic and mediastinal disorders Shortness of breath, minor respiratory infections	1.8% 4/223 • Number of events 6 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	2.3% 5/220 • Number of events 6 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Reproductive system and breast disorders Uterine fibroid	0.00% 0/223 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Endocrine disorders Diabetes-related complications	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.45% 1/220 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Surgical and medical procedures Minor outpatient surgical procedures	1.3% 3/223 • Number of events 3 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Ear and labyrinth disorders Ear infection	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Infections and infestations Misc non-systemic infections	0.90% 2/223 • Number of events 2 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
Skin and subcutaneous tissue disorders Rash	0.45% 1/223 • Number of events 1 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.	0.00% 0/220 • Randomization through 12 months (active intervention phase) We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.