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Evaluation of a Commercial Program on Weight Loss and Health Outcomes

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: NCT03037567
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this study is to examine the acceptability and efficacy of a modified Weight Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Modified Weight Watchers plan Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified Weight Watchers plan
Modified Weight Watchers Plan which includes a food plan, activity plan, group support and cognitive behavior modification. Weekly study-specific group meetings; electronic tools through iPhone app for 24 weeks.
Behavioral: Modified Weight Watchers plan
Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.




Primary Outcome Measures :
  1. Weight Change [ Time Frame: 0 - 6 months ]
    Mean Change in body weight (kg) Body weight will be assessed on a calibrated digital scale and recorded to the nearest 0.1 kg.


Secondary Outcome Measures :
  1. Achieving a weight loss of 5% or more [ Time Frame: 0 - 6 months ]
    % participants achieving a weight loss of 5% initial body weight or more

  2. Achieving a weight loss of 5% or more [ Time Frame: 0 - 3 months ]
    % participants achieving a weight loss of 5% initial body weight or more

  3. Weight Change [ Time Frame: 0 - 3 months ]
    Mean Change in body weight (kg)

  4. Waist circumference change (cm) (mean) [ Time Frame: 0 - 3 months ]
    Waist circumference will be measured at the iliac crest

  5. Waist circumference change (cm) (mean) [ Time Frame: 0 - 6 months ]
    Waist circumference will be measured at the iliac crest

  6. Relationship between fitness, flexibility and psychosocial measures with weight change [ Time Frame: 0 - 6 months ]
    The relationship between weight change and any of these measures will be assessed.



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:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 25 and 43 kg/m²
  • Ability to read and speak English
  • All ethnic groups will be recruited
  • Self-report desire to lose weight and willing to follow study recommendations
  • Use of an iPhone with iOS 8.0 or later for use on a daily basis, and basic app skills
  • Have access to the internet via a computer, and basic computer skills

Exclusion Criteria:

  • Currently following a commercial weight-loss program (including Weight Watchers) or who followed a weight loss program in the previous 6 months or who were members of Weight Watchers within the past 12 months
  • Another member of the household participating in the study.
  • Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
  • Planning to relocate in the next 9 months
  • Involvement in another research study that would interfere with participation in this study
  • Excessive alcohol intake or dependence
  • Recent weight loss of ≥ 5 kg in the previous 6 months.
  • Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems, history or heart attack or stroke)
  • History of clinically diagnosed eating disorder.
  • Untreated thyroid disease or and changes in dose or type of thyroid medication over previous 6 months
  • Chronic/inflammatory gastrointestinal disorders (Irritable Bowel Syndrome acceptable)
  • Taking any prescription medication with known effects on appetite or weight
  • Previous surgical procedure for weight loss.
  • Major surgery within the previous 6 months.
  • Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
  • Diuretic use over 1.5mg per day
  • Diagnosis of type 1 or type 2 diabetes
  • Presence of implanted cardiac defibrillator or pacemaker.
  • History of presence of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment

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): NCT03037567


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Weight Watchers International
Investigators
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Principal Investigator: Deborah F Tate, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03037567     History of Changes
Other Study ID Numbers: 16-3421
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
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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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes