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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302389
Recruitment Status : Suspended (due to COVID-19)
First Posted : March 10, 2020
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

Brief Summary:
The goal of the proposed research project is to evaluate the feasibility, acceptability, and preliminary outcomes of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and outcomes.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Virtual Group Coaching Program Not Applicable

Detailed Description:

Technology is changing the delivery of behavioral weight loss programs and providing a way to extend reach to wider audiences. Commercial programs that were once completely delivered via in person meetings at brick-and-mortar businesses are now being converted into online 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. The WW program includes a mobile app that helps people follow the WW SmartPoints Program, rewards for consistent tracking, an online community to connect with other users, and a 24/7 text chat with coaches function. WW also recently developed a virtual group coaching program that places 75-100 users into private groups where they receive educational content and support from each other and a coach.

Previous research by the investigators and others reveals that greater engagement in online group-based weight loss programs is associated with greater weight loss. Investigators have also found that an online group coaching program paired with a calorie tracking mobile app is effective at producing weight loss. WW has done a "soft launch" of the virtual group coaching program on their platform. WW is sponsoring this project to perform a one-arm trial of the WW comprehensive online weight loss program that includes the virtual group coaching program. Findings will inform the continued development of the virtual group coaching program and extend the literature on how people engage in online weight loss programs. Project aims are as follows: 1) To examine the feasibility, acceptability, and preliminary outcomes of a multicomponent online commercial weight loss program that includes a mobile app, incentives for tracking, 24/7 coaching, an online community, and virtual group coaching. Feasibility is defined as use of each component, engagement in the online community and virtual group coaching, and incentives (WellnessWins) earned. Acceptability of each program component and the overall program will be evaluated at 6 months. 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, food cravings, and mood from baseline to 6 months. 2) To examine whether greater overall engagement in the virtual group, greater engagement with coaches, greater total engagement with peers in the virtual group and online community, and engagement with a higher number of peers (in virtual group and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This project includes a one-arm trial to evaluate the WW's virtual group coaching program.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Group Coaching Program
This 6-month intervention includes the use of three components: WW's mobile app, Virtual Group Coaching (VGC), and Connect (an online community that has no coach posts). The WW weight loss curriculum involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh in with the coach via a private direct message function. The coach will post videos and start conversation threads in the VGC group based on the topic of the week. Participants will be encouraged to use the app and the virtual coaching group daily.
Behavioral: Virtual Group Coaching Program
The 6-month intervention includes the use of WW's mobile app, Virtual Group Coaching (VGC), and Connect. The WW app sets members up with a personal food plan. The app will track daily SmartPoints Budget, which is how users keep track of their daily dietary intake and physical activity. The app also provides recipes, and provides access 24/7 to text chat with WW coaches. VGC is offered through the WW app and provides one-on-one and group support from a WW coach. The group will be managed by 1-2 coaches who are WW employees. The coach will help with goal setting, troubleshoot challenges, and follow-up on progress toward goals each week. Connect is WW's online community that gives members an opportunity to receive motivational support from each other. Members can post about their journey through photos, videos, and comments. Members can also choose Connect Groups to join, which are "chat rooms" based on WW progress, location, interests, age, or hobbies.




Primary Outcome Measures :
  1. Intervention Use [ Time Frame: 6 months ]
    Feasibility of the intervention will be assessed by measuring use of each app feature, which includes engagement in the online community, virtual group coaching, and incentives (WellnessWins) earned.

  2. Participant Intervention Feedback [ Time Frame: 6 months ]
    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.

  3. Change in Weight [ Time Frame: Baseline to 3-months ]
    Weight will be measured using a Wi-Fi scale at all assessments. Weight change will be measured from baseline to 3-months.

  4. Change in Weight [ Time Frame: Baseline to 6-months ]
    Weight will be measured using a Wi-Fi scale at all assessments. Weight change will be measured from baseline to 6-months.


Secondary Outcome Measures :
  1. Change in Diet Quality [ Time Frame: Baseline to 6-months ]
    Diet quality changed will be measured from baseline to 6-months using a dietary screener Starting The Conversation. This is an 8-item measure with answers ranging from 0-2. The score is the sum of all answers, range 0-16, with lower scores indicating healthier eating.

  2. Change in Physical Activity [ Time Frame: 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.

  3. Changes in Quality of Life [ Time Frame: Baseline to 6-months ]
    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.

  4. Changes in Sleep Quality [ Time Frame: 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.

  5. Changes in Food Cravings [ Time Frame: Baseline to 6-months ]
    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.

  6. Changes in Mood [ Time Frame: Baseline to 6 months ]
    Changes in mood as measured by the Positive and Negative Affect Schedule (PANAS) will be measured from baseline to 6-months. Scores for positive affect range from 10 - 50, with higher scores representing higher levels of positive affect. Scores for negative affect range from 10 - 50, with higher scores representing higher levels of negative affect.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-75 years old.
  2. BMI 25-45 kg/m2.
  3. Has Wi-Fi connectivity at home (for Wi-Fi scale).
  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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302389


Locations
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United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Weight Watchers International
Investigators
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Principal Investigator: Sherry Pagoto, PhD University of Connecticut
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Responsible Party: Sherry Pagoto, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT04302389    
Other Study ID Numbers: H20-0030
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes