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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

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
body weight change (kg) [ Time Frame: baseline to six months ]
average body weight change (kg) from baseline to six months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03928483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • 3-month change in weight (kg) [ Time Frame: baseline to 3-months ]
    average 3-month change in weight (kg)
  • 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
  • 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
  • changes in Body Mass Index (BMI) [ Time Frame: baseline, 3-months and 6-months ]
    changes in Body Mass Index (BMI)
  • 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.
  • flexibility [ Time Frame: baseline, 3-months and 6-months ]
    change in flexibility as measured via standard sit-and-reach protocol
  • aerobic stamina [ Time Frame: baseline, 3-months and 6-months ]
    change in aerobic stamina as measured with the 6-minute walk test
  • blood pressure [ Time Frame: baseline, 3-months and 6-months ]
    change in blood pressure as measured by a blood pressure monitor
  • food cravings [ Time Frame: baseline, 3-months and 6-months ]
    change in reported food cravings as measured by the FCI-II
  • happiness [ Time Frame: baseline, 3-months and 6-months ]
    change in reported happiness as measured using the Oxford Happiness Questionnaire
  • 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
  • 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)
  • 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
  • personal food assessment [ Time Frame: baseline and 6-months ]
    changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire
  • program satisfaction: WW generated satisfaction questionnaire [ Time Frame: 3-months and 6-months ]
    program satisfaction as measured by the WW generated satisfaction questionnaire
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Official Title  ICMJE Evaluation of a Commercial Program on Weight Loss and Health Outcomes
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Obesity
  • Weight Loss
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Modified WW Food program
Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Intervention: Behavioral: Modified WW Food program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928483
Other Study ID Numbers  ICMJE Pro00085970
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE WW International
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP