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Evaluation of a Commercial Program on Weight Loss and Health Outcomes

NCT ID: NCT03928483

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2019-11-07

Brief Summary

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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

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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.

Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This single-armed trial will have one condition: the modified WW Food program.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified WW Food program

Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.

Group Type EXPERIMENTAL

Modified WW Food program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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WW International Inc

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00085970

Identifier Type: -

Identifier Source: org_study_id