Obesity Clinical Trial
Official title:
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Verified date | December 2019 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | November 7, 2019 |
Est. primary completion date | November 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | WW International |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | body weight change (kg) | average body weight change (kg) from baseline to six months | baseline to six months | |
Secondary | 3-month change in weight (kg) | average 3-month change in weight (kg) | baseline to 3-months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | changes in Body Mass Index (BMI) | changes in Body Mass Index (BMI) | baseline, 3-months and 6-months | |
Secondary | waist circumference | change in waist circumference as measured at natural waist with a non-stretch tape measure. | baseline, 3-months and 6-months | |
Secondary | flexibility | change in flexibility as measured via standard sit-and-reach protocol | baseline, 3-months and 6-months | |
Secondary | aerobic stamina | change in aerobic stamina as measured with the 6-minute walk test | baseline, 3-months and 6-months | |
Secondary | blood pressure | change in blood pressure as measured by a blood pressure monitor | baseline, 3-months and 6-months | |
Secondary | food cravings | change in reported food cravings as measured by the FCI-II | baseline, 3-months and 6-months | |
Secondary | happiness | change in reported happiness as measured using the Oxford Happiness Questionnaire | baseline, 3-months and 6-months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | subjective sensations of hunger | change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale | baseline, 3-months and 6-months | |
Secondary | personal food assessment | changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire | baseline and 6-months | |
Secondary | program satisfaction: WW generated satisfaction questionnaire | program satisfaction as measured by the WW generated satisfaction questionnaire | 3-months and 6-months | |
Secondary | 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 |
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