Clinical trial NCT03928483: Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Official title: Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Weight Loss
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2019-04-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This single-armed trial will have one condition: the modified WW Food program.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: body weight change (kg)
timeFrame: baseline to six months
Secondary outcomes:
measure: 3-month change in weight (kg)
timeFrame: baseline to 3-months
measure: 3-month change in weight, as a percentage of start weight
timeFrame: baseline to 3-months
measure: 6-month changes in body weight as a percentage of start weight
timeFrame: baseline to 6-months
measure: changes in Body Mass Index (BMI)
timeFrame: baseline, 3-months and 6-months
measure: waist circumference
timeFrame: baseline, 3-months and 6-months
measure: flexibility
timeFrame: baseline, 3-months and 6-months
measure: aerobic stamina
timeFrame: baseline, 3-months and 6-months
measure: blood pressure
timeFrame: baseline, 3-months and 6-months
measure: food cravings
timeFrame: baseline, 3-months and 6-months
measure: happiness
timeFrame: baseline, 3-months and 6-months
measure: sleep quality and duration: Pittsburgh Sleep Quality Index
timeFrame: baseline, 3-months and 6-months
measure: weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)
timeFrame: baseline, 3-months and 6-months
measure: subjective sensations of hunger
timeFrame: baseline, 3-months and 6-months
measure: personal food assessment
timeFrame: baseline and 6-months
measure: program satisfaction: WW generated satisfaction questionnaire
timeFrame: 3-months and 6-months
measure: health related quality of life: SF-36
timeFrame: baseline, 3-months and 6-months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: