NCT04302389

Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program

Completed NA Results posted Last updated 7 August 2025

What this trial tests

NA trial testing myWW App, Virtual Workshops, and Private Facebook Group in Weight Loss in 153 participants. Completed in 1 November 2021.

Timeline

10 February 2021

Primary endpoint
1 November 2021

1 November 2021

Quick facts

Lead sponsor	University of Connecticut
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	153
Start date	10 February 2021
Primary completion	1 November 2021
Estimated completion	1 November 2021
Sites	1 location across United States

Drugs / interventions tested

• myWW App, Virtual Workshops, and Private Facebook Group

Conditions studied

• Weight Loss — all drugs for Weight Loss →

Sponsor

University of Connecticut

Who can join

Adults 18 to 75, any sex, with Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Days Diet Tracking Feature Was Used in App Primary · 6 months

Percent of days participants used the diet tracking feature in the WW app during the intervention to track their daily food intake. A day of use will be defined as a day where participants tracked any food item in the WW app.

Group	Value	95% CI
Lifestyle Modification Program	39.1	± 30.8

Intervention Acceptability Primary · 6 months

Percent of participants who agree or strongly agree that the program made them feel healthier.

Group	Value	95% CI
Lifestyle Modification Program	102

Percent Change in Weight From Baseline to 3 Months Primary · Baseline to 3-months

Weight was measured using a smart scale at baseline and at the three month assessment.

Group	Value	95% CI
Lifestyle Modification Program	-8.19	± 7.51

Weight Change in Pounds From Baseline to 6 Months Primary · Baseline to 6-months

Weight will be measured using a smart scale at all assessments. Weight change will be calculated as weight at 6 months in pounds minus baseline weight in pounds. Lower values mean more weight loss.

Group	Value	95% CI
Lifestyle Modification Program	-9.72	± 10.78

Number of Days Physical Activity Tracking Feature Was Used in App Primary · 6 months

Number of days participants used the physical activity feature in the WW app during the intervention. A day of use will be defined as any day in which any physical activity was logged. Total days possible = 168 days.

Group	Value	95% CI
Lifestyle Modification Program	106.37	± 73.22

Number of Weekly Virtual Workshops Attended Primary · 6 months

Number of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops.

Group	Value	95% CI
Lifestyle Modification Program	9.68	± 7.16

Number of Weekly Check Ins Attended Primary · 6 months

Number of weekly check ins completed by participants during the program. During the 6-month intervention, there were 24 opportunities for weekly check ins. Higher numbers mean more weekly check ins were completed.

Group	Value	95% CI
Lifestyle Modification Program	11.91	± 7.63

Number of Weeks Participants Engaged in the Private, Online Community Primary · 6 months

All posts, comments, and reactions made in the Facebook group were captured using Grytics for Facebook each of the 24 weeks of the intervention. Participants were considered engaged with the intervention by making at least one post, one comment, and/or one reaction (e.g., like) during the intervention week. Values could range from 0 to 24 weeks with higher numbers indicating more frequent engagement in the intervention.

Group	Value	95% CI
Lifestyle Modification Program	6.03	± 7.03

Weight Change in Pounds From Baseline to 3 Months Primary · 3 months

Weight will be assessed via digital scales provided to participants. Weight change will be calculated by subtracting weight in pounds at 3 months from baseline weight. Lower values indicate greater weight loss in pounds.

Group	Value	95% CI
Lifestyle Modification Program	-8.19	± 7.51

Percent Weight Change From Baseline to 6 Months Primary · 6 months

Weight is assessed via digital scales provided to participants. Percent weight change will be calculated by subtracting 6 month weight in pounds from baseline weight in pounds, dividing by baseline weight in pounds, and then multiplying this number by 100. Lower values indicated greater weight loss.

Group	Value	95% CI
Lifestyle Modification Program	-5.05	± 5.59

Change in Fruit Intake Score Secondary · Baseline to 6-months

At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruit intake. 1 assessed fruit intake. Change in fruit intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in fruit intake.

Group	Value	95% CI
Lifestyle Modification Program	.18	± .82

Change in Physical Activity Secondary · Baseline to 6-months

Changes in physical activity will be measured from baseline to 6-months using the Global Physical Activity Questionnaire (GPAQ). The GPAQ has questions assessing activity at work, travel to and from places, and recreational activities. The number of minutes spent on each activity is assigned a METs value to determine level of energy expenditure. The higher the METs value the higher the activity level.

Group	Value	95% CI
Lifestyle Modification Program	783.95	± 3611.88

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lifestyle Modification Program

Serious: 13/153 (8%)

Deaths: 0/153

Serious adverse events (13 terms)

Reaction	System	Lifestyle Modification Pro…
heart attack	Cardiac disorders	—
broken leg	Musculoskeletal and connective tissue disorders	—
multiple sclerosis flare up	Musculoskeletal and connective tissue disorders	—
diverticulitis	Gastrointestinal disorders	—
Hernia	Musculoskeletal and connective tissue disorders	—
Fall	Musculoskeletal and connective tissue disorders	—
hysterectomy	Reproductive system and breast disorders	—
sarcoidosis	Blood and lymphatic system disorders	—
Sarcoidosis flare up	Blood and lymphatic system disorders	—
tardive dyskinesia	Musculoskeletal and connective tissue disorders	—
thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
eosinophilic gastrointestinal disease (EGID)	Gastrointestinal disorders	—
tubal ligation	Reproductive system and breast disorders	—

Most-reported serious reactions: heart attack, broken leg, multiple sclerosis flare up, diverticulitis, Hernia, Fall, hysterectomy, sarcoidosis.

Data from ClinicalTrials.gov NCT04302389 adverse events section.

Sponsor's own description

The goal of the proposed research project is to evaluate the acceptability and efficacy of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and weight loss and health outcomes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Evaluation of a Personalized Multicomponent Commercial Digital Weight Management Program: Single-Arm Behavioral Trial.
   Pagoto S, Xu R, Bullard T, Foster GD, et al · · 2023 · cited 10× · PMID 37642986 · DOI 10.2196/44955
2. "Click and mortar" opportunities for digitization and consumerism in trials.
   Randell RL, Hornik CP, Curtis L, Hernandez AF, et al · · 2023 · cited 1× · PMID 37481202 · DOI 10.1016/j.cct.2023.107304