Evaluation of a Commercial Program on Weight Loss and Health Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Modified WW Food program

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: Interventional
• Enrollment (Actual): 143
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight change (kg)	average body weight change (kg) from baseline to six months	baseline to six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month change in weight (kg)	average 3-month change in weight (kg)	baseline to 3-months
3-month change in weight, as a percentage of start weight	3-month change in weight, as a percentage of start weight	baseline to 3-months
6-month changes in body weight as a percentage of start weight	6-month changes in body weight as a percentage of start weight	baseline to 6-months
changes in Body Mass Index (BMI)	changes in Body Mass Index (BMI)	baseline, 3-months and 6-months
waist circumference	change in waist circumference as measured at natural waist with a non-stretch tape measure.	baseline, 3-months and 6-months
flexibility	change in flexibility as measured via standard sit-and-reach protocol	baseline, 3-months and 6-months
aerobic stamina	change in aerobic stamina as measured with the 6-minute walk test	baseline, 3-months and 6-months
blood pressure	change in blood pressure as measured by a blood pressure monitor	baseline, 3-months and 6-months
food cravings	change in reported food cravings as measured by the FCI-II	baseline, 3-months and 6-months
happiness	change in reported happiness as measured using the Oxford Happiness Questionnaire	baseline, 3-months and 6-months
sleep quality and duration: Pittsburgh Sleep Quality Index	change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index	baseline, 3-months and 6-months
weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)	change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)	baseline, 3-months and 6-months
subjective sensations of hunger	change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale	baseline, 3-months and 6-months
personal food assessment	changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire	baseline and 6-months
program satisfaction: WW generated satisfaction questionnaire	program satisfaction as measured by the WW generated satisfaction questionnaire	3-months and 6-months
health related quality of life: SF-36	changes in reported health related quality of life as measured through the SF-36	baseline, 3-months and 6-months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: WW International

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ACTUAL): November 7, 2019
• Study Completion (ACTUAL): November 7, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: Pro00085970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No