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Completed

NCT Number: NCT03928483

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified WW Food program

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.

Primary outcomes

  1. body weight change (kg)

    Time frame: baseline to six months

    average body weight change (kg) from baseline to six months

Secondary outcomes

  1. 3-month change in weight (kg)

    Time frame: baseline to 3-months

    average 3-month change in weight (kg)

  2. 3-month change in weight, as a percentage of start weight

    Time frame: baseline to 3-months

    3-month change in weight, as a percentage of start weight

  3. 6-month changes in body weight as a percentage of start weight

    Time frame: baseline to 6-months

    6-month changes in body weight as a percentage of start weight

  4. changes in Body Mass Index (BMI)

    Time frame: baseline, 3-months and 6-months

    changes in Body Mass Index (BMI)

  5. waist circumference

    Time frame: baseline, 3-months and 6-months

    change in waist circumference as measured at natural waist with a non-stretch tape measure.

  6. flexibility

    Time frame: baseline, 3-months and 6-months

    change in flexibility as measured via standard sit-and-reach protocol

  7. aerobic stamina

    Time frame: baseline, 3-months and 6-months

    change in aerobic stamina as measured with the 6-minute walk test

  8. blood pressure

    Time frame: baseline, 3-months and 6-months

    change in blood pressure as measured by a blood pressure monitor

  9. food cravings

    Time frame: baseline, 3-months and 6-months

    change in reported food cravings as measured by the FCI-II

  10. happiness

    Time frame: baseline, 3-months and 6-months

    change in reported happiness as measured using the Oxford Happiness Questionnaire

  11. sleep quality and duration: Pittsburgh Sleep Quality Index

    Time frame: baseline, 3-months and 6-months

    change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index

  12. weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)

    Time frame: baseline, 3-months and 6-months

    change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)

  13. subjective sensations of hunger

    Time frame: baseline, 3-months and 6-months

    change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale

  14. personal food assessment

    Time frame: baseline and 6-months

    changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire

  15. program satisfaction: WW generated satisfaction questionnaire

    Time frame: 3-months and 6-months

    program satisfaction as measured by the WW generated satisfaction questionnaire

  16. health related quality of life: SF-36

    Time frame: baseline, 3-months and 6-months

    changes in reported health related quality of life as measured through the SF-36

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • WW International Inc

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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