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

Not Applicable

Completed

Conditions: Weight Loss

Registration Number: NCT04302389

Lead Sponsor: University of Connecticut

Brief Summary: 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.

Detailed Description: Technology is changing the opportunities to deliver behavioral weight loss programs and providing a way to extend their reach to wider audiences. Commercial programs that were once completely delivered via in person meetings at brick-and-mortar businesses are now expanding to virtual programs. WW (formerly known as Weight Watchers) is an industry leader and one of few commercial programs that has significant evidence for efficacy on weight loss. Their program currently includes a mobile app - that helps people follow the WW Program, rewards for consistent tracking and achieving milestones, an online community to connect with other users, and a 24/7 text chat with coaches.

Previous research by the investigators and others reveals that greater engagement in an online group-based weight loss program is associated with greater weight loss. We have found that an online group coaching program paired with a calorie tracking mobile app is effective at producing weight loss. WW is testing a new comprehensive program that involves an updated program paired with virtual workshops that offer actionable behavior change techniques for members, led by a trained WW coach. They have agreed to fund us to perform a one-arm trial of their new comprehensive program that includes a holistic approach to healthy lifestyle (activity, diet, and mindset). Findings will inform the continued development of this program. Our aims are as follows: 1) To examine the preliminary outcomes and acceptability of a multicomponent online commercial weight loss program that includes a mobile app, incentives for tracking, weekly virtual workshops, and an online community. Preliminary outcome is defined as weight change from baseline to 3 and 6-months. Secondary preliminary outcomes include changes in diet quality, physical activity, quality of life, sleep quality, and food cravings from baseline to 6 months. Acceptability of each program component and the overall program will be evaluated at 6 months. 2) To examine whether greater app use, greater engagement in the online community, and engagement with a higher number of peers (in the online community) predict greater weight loss at 3- and 6-months. 3) To examine the associations between total use of program components (and each individual program component) and change in weight. We hypothesize that greater use of program components (individually and total) will predict greater weight loss.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 153

Inclusion Criteria

18-75 years old.
BMI 25-45 kg/m2.
Has Wi-Fi connectivity at home
Able to participate in the study in English.
Self-reported desire to lose weight.
Willing to follow recommendations required by study protocol.
Willing to include demographic information (e.g., ethnicity, income and education)
Lives in the United States

Exclusion Criteria

Pregnant, lactating, or plans to become pregnant during study period.
Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression.
Had bariatric surgery or plans to have any surgery during the study
Unable to make dietary changes or increase physical activity.
Unable to walk ¼ mile unaided without stopping
Smoker or use nicotine vape daily.
Participants that are currently, or within the last 6 months, trying to lose weight via a structured weight-loss program (e.g., at a medical center, university, commercial programs)
Participants who were a member of WW within the past 12 months.
Participants who are involved in any other research studies at this time.
Weight loss of ≥ 5 kg in the previous 6 months.
Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, orthopedic limitations, heart problems).
Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months.
Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
Diagnosis of type 1 or type 2 diabetes.
Major surgery within the previous 6 months.
Presence of implanted cardiac defibrillator or pacemaker.
History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
Meets criteria for severe depression on the PHQ-9 (score of >20) or endorsement of "Thoughts that you would be better off dead, or of hurting yourself in some way".
Hospitalization for psychiatric disorders during the past 12 months.
Not willing to sign an NDA; or indicated they do not want to agree to NDA's terms.
Unable to attend any virtual workshop meeting times.
Does not have an iPhone.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of Days Diet Tracking Feature Was Used in App	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.
Intervention Acceptability	6 months	Percent of participants who agree or strongly agree that the program made them feel healthier.
Percent Change in Weight From Baseline to 3 Months	Baseline to 3-months	Weight was measured using a smart scale at baseline and at the three month assessment.
Weight Change in Pounds From Baseline to 6 Months	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.
Number of Days Physical Activity Tracking Feature Was Used in App	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.
Number of Weekly Virtual Workshops Attended	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.
Number of Weekly Check Ins Attended	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.
Number of Weeks Participants Engaged in the Private, Online Community	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.
Weight Change in Pounds From Baseline to 3 Months	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.
Percent Weight Change From Baseline to 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Food Cravings	Baseline to 6-months	Changes in food cravings will be measured from baseline to 6-months using the Food Craving Inventory. This inventory includes 28 foods that are scored based on level of craving ranging in answers from 1 (Never) to 5 (Always) for each. A mean is calculated across the 28 items. Scores then would range from a minimum of 1 to a maximum of 5. Higher scores indicate more frequent cravings. Change was calculated by subtracting 6 month scores from baseline scores. Higher scores indicate greater increases in food cravings.
Change in Fruit Intake Score	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.
Change in Physical Activity	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.
Changes in Quality of Life	Baseline to 6-months	Changes in weight related quality of life will be measured from baseline to 6-months using the Impact of Weight on Quality of Life-Lite. This is a 31-item measure assessing physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Scores range from 0-100, with 100 representing the best quality of life. Change was calculated by subtracting 6 month scores from baseline scores. Higher values indicate greater increases in quality of life.
Changes in Sleep Quality	Baseline to 6-months	Changes in sleep quality will be measured from baseline to 6-months using the Pittsburgh Sleep Quality Index. This measure contains 10 items to assess sleep quality with a score possible score of 0 - 21. Lower scores represent better the sleep quality (\< 5 is associated with good sleep quality; \> 5 is associated with poor sleep quality. Change in sleep quality was calculated by subtracting 6 month scores from baseline scores. Lower values indicate improvements in sleep quality.
Changes in Hunger	Baseline to 6-months	Changes in hunger will be measured from baseline to 6-months using the Hunger VAS (Visual Analogue Scale). This one-question measure asks "How hungry did you feel over the past week" and is composed of a slider with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants rated their hunger over the past week using a slider on a visual analog scale ranging from 0=not at all hungry to 100=extremely hungry. Change in hunger was then calculated by subtracting the hunger score at 6 months from the hunger score at baseline. Higher values indicate increases in hunger over time and lower values indicate decreases in hunger over time.
Changes in Positive Behavioral Automaticity	Baseline to 6-months	Changes in behavioral automaticity will be measured using the Self-Report Behavioral Automaticity Index (SRBAI). This 4-item measure assesses whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree. A mean score was calculated for each behavior. Then, mean scores were calculated for the 7 healthy behaviors to produce a positive behavioral automaticity score which could range from 1 to 7. Change in positive behavioral automaticity was then calculated by subtracting the 6 month value from the baseline value. Higher scores indicate greater behavioral automaticity for healthy behaviors.
Changes in Self-Compassion	Baseline to 6-months	Changes in self-compassion will be measured using the Self-Compassion Scale. This is a 26-item measure of self-compassion that consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Items were rated a scale ranging from 1=almost never to 5=almost always. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means. The total possible scores range from 1-5. Then to calculate change in self-compassion, we subtracted the 6 month value from the baseline value. Higher scores mean greater increases in self-compassion over time.
Change in Well-being	Baseline to 6-months	Changes in well-being will be measured using the WHO-5 Well Being Index (0-100 score where higher scores mean greater well-being). Change in well-being was then calculated by subtracting the 6 month score from the baseline score. Higher values indicate increases in well-being over time.
Change in Vegetable Intake Score	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 fruits and vegetables. 1 assessed vegetable intake. Change in vegetable intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in vegetable intake.
Change in Salad Intake Score	baseline and 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 fruits and vegetables. 1 assessed salad intake. Change in salad intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in salad intake.