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Evaluation of a Commercial Program on Weight Loss and Health Outcomes

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ClinicalTrials.gov Identifier: NCT03928483
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
WW International
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Behavioral: Modified WW Food program Early Phase 1

Detailed Description:
This trial is an examination of a modified WW food program. The intention is to document the acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a program similar to WW Freestyle and have access to study-specific weekly workshops and a suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW program, participants are provided instructions on calculating points for the foods and beverages they eat and drink. This study will examine the impact of the modified WW food program on weight and fitness levels of adults with overweight and obesity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This single-armed trial will have one condition: the modified WW Food program.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified WW Food program
Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Behavioral: Modified WW Food program
Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset.




Primary Outcome Measures :
  1. body weight change (kg) [ Time Frame: baseline to six months ]
    average body weight change (kg) from baseline to six months


Secondary Outcome Measures :
  1. 3-month change in weight (kg) [ Time Frame: baseline to 3-months ]
    average 3-month change in weight (kg)

  2. 3-month change in weight, as a percentage of start weight [ Time Frame: baseline to 3-months ]
    3-month change in weight, as a percentage of start weight

  3. 6-month changes in body weight as a percentage of start weight [ Time Frame: baseline to 6-months ]
    6-month changes in body weight as a percentage of start weight

  4. changes in Body Mass Index (BMI) [ Time Frame: baseline, 3-months and 6-months ]
    changes in Body Mass Index (BMI)

  5. waist circumference [ Time Frame: baseline, 3-months and 6-months ]
    change in waist circumference as measured at natural waist with a non-stretch tape measure.

  6. flexibility [ Time Frame: baseline, 3-months and 6-months ]
    change in flexibility as measured via standard sit-and-reach protocol

  7. aerobic stamina [ Time Frame: baseline, 3-months and 6-months ]
    change in aerobic stamina as measured with the 6-minute walk test

  8. blood pressure [ Time Frame: baseline, 3-months and 6-months ]
    change in blood pressure as measured by a blood pressure monitor

  9. food cravings [ Time Frame: baseline, 3-months and 6-months ]
    change in reported food cravings as measured by the FCI-II

  10. happiness [ Time Frame: baseline, 3-months and 6-months ]
    change in reported happiness as measured using the Oxford Happiness Questionnaire

  11. sleep quality and duration: Pittsburgh Sleep Quality Index [ Time Frame: baseline, 3-months and 6-months ]
    change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index

  12. weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite) [ Time Frame: baseline, 3-months and 6-months ]
    change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)

  13. subjective sensations of hunger [ Time Frame: baseline, 3-months and 6-months ]
    change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale

  14. personal food assessment [ Time Frame: baseline and 6-months ]
    changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire

  15. program satisfaction: WW generated satisfaction questionnaire [ Time Frame: 3-months and 6-months ]
    program satisfaction as measured by the WW generated satisfaction questionnaire

  16. health related quality of life: SF-36 [ Time Frame: baseline, 3-months and 6-months ]
    changes in reported health related quality of life as measured through the SF-36



Information from the National Library of Medicine

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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:

  • Ages 18-75 years
  • Body Mass Index (BMI) of 25 to 43
  • Self-reported desire to lose weight
  • Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
  • Willing to follow recommendations required by study protocol
  • Willing to include demographic information (e.g., ethnicity, income and education)
  • Use of a personal iPhone on a daily basis
  • Basic app skills
  • Reliable home Wi-Fi access
  • Ability to commit to attending up to 27 study visits in approximately 26 weeks

Exclusion Criteria

  • Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or 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 (also, cannot join other research studies while in this study, over the next 6 months).
  • Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
  • Weight loss of ≥ 5 kg in the previous 6 months.
  • History of clinically diagnosed eating disorder.
  • Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., 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
  • Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
  • 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.
  • Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
  • Diagnosis of type 1 or type 2 diabetes
  • Previous surgical procedure for weight loss.
  • 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).
  • Hospitalization for psychiatric disorders during the past 12 months
  • Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
  • Planning to relocate in the next 9 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): NCT03928483


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
WW International

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03928483     History of Changes
Other Study ID Numbers: Pro00085970
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
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