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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04302389
• Other study ID #: H20-0030
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old.

2. BMI 25-45 kg/m2.

3. Has Wi-Fi connectivity at home

4. Able to participate in the study in English.

5. Self-reported desire to lose weight.

6. Willing to follow recommendations required by study protocol.

7. Willing to include demographic information (e.g., ethnicity, income and education)

8. Lives in the United States

Exclusion Criteria:

1. Pregnant, lactating, or plans to become pregnant during study period.

2. Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression.

3. Had bariatric surgery or plans to have any surgery during the study

4. Unable to make dietary changes or increase physical activity.

5. Unable to walk ¼ mile unaided without stopping

6. Smoker or use nicotine vape daily.

7. 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)

8. Participants who were a member of WW within the past 12 months.

9. Participants who are involved in any other research studies at this time.

10. Weight loss of = 5 kg in the previous 6 months.

11. Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, orthopedic limitations, heart problems).

12. Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.

13. 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.

14. Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).

15. History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.

16. Diagnosis of type 1 or type 2 diabetes.

17. Major surgery within the previous 6 months.

18. Presence of implanted cardiac defibrillator or pacemaker.

19. 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).

20. 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".

21. Hospitalization for psychiatric disorders during the past 12 months.

22. Not willing to sign an NDA; or indivated they do not want to agree to NDA's terms.

23. Unable to attend any virtual workshop meeting times.

24. Does not have an iPhone.

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• myWW App, Virtual Workshops, and Private Facebook Group
The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals each week. Participants will be encouraged to participate in a private Facebook group that gives participants an opportunity to receive motivational support from each other. Participants can post about their journey through photos, videos, and comments.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Use	Feasibility of the intervention will be assessed by measuring use of each app feature, engagement in the online community (via Grytics for Facebook), and attendance of virtual workshops.	6 months
Primary	Intervention acceptability	Participants will answer questions related to their experience with each program. Acceptability of the intervention will be assessed using a satisfaction survey at the end of the program asking about all intervention components and the overall program.	6 months
Primary	Change in Weight	Weight will be measured using a smart scale at all assessments. Weight change will be measured from baseline to 3-months.	Baseline to 3-months
Primary	Change in Weight	Weight will be measured using a smart scale at all assessments. Weight change will be measured from baseline to 6-months.	Baseline to 6-months
Secondary	Change in Diet	Changes in diet will be measured from baseline to 6-months using the 5 Factor Screener 2005 NHIS. This is a 19-item measure assessing approximate intakes of fruits and vegetables, fiber, added sugar, calcium, red meat, and cereal. The screener asks respondents to report how frequently they consume foods in 18 categories. No portion size questions are asked.	Baseline to 6-months
Secondary	Change in Physical Activity	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.	Baseline to 6-months
Secondary	Changes in Quality of Life	Changes in 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.	Baseline to 6-months
Secondary	Changes in Sleep Quality	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.	Baseline to 6-months
Secondary	Changes in Food Cravings	Changes in food cravings will be measured from baseline to 6-months using the Food Craving Inventory. This inventory includes 33 foods that are scored based on level of craving ranging in answers from 1 (Not at all) to 5 (Extremely) for each.	Baseline to 6-months
Secondary	Changes in Hunger	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 line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.	Baseline to 6-months
Secondary	Changes in Behavioral Automaticity	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.	Baseline to 6-months
Secondary	Changes in Self-Compassion	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. 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.	Baseline to 6-months
Secondary	Change in Well-being	Changes in well-being will be measured using the WHO-5 Well Being Index	Baseline to 6-months