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ObesityEarly Phase 1NCT03928483

Evaluation of a Commercial Program on Weight Loss and Health Outcomes

A Early Phase 1 study testing Modified WW Food program in people with Obesity and Weight Loss, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Weight Loss
What is being tested?
Modified WW Food program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteUnited States
Study dates
18 Mar 2019to 7 Nov 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity, Weight Loss
Being tested
Modified WW Food program
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified WW Food programBehavioural

    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.

Study groups in NCT03928483
Study groupRoleWhat they receive
Modified WW Food programExperimentalParticipants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Receives: Behavioral: Modified WW Food program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body weight change (kg)

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

    Measured: baseline to six months

Secondary outcomes (16)

  1. 3-month change in weight (kg)

    average 3-month change in weight (kg)

    Measured: baseline to 3-months

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

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

    Measured: baseline to 3-months

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

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

    Measured: baseline to 6-months

  4. changes in Body Mass Index (BMI)

    changes in Body Mass Index (BMI)

    Measured: baseline, 3-months and 6-months

  5. waist circumference

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

    Measured: baseline, 3-months and 6-months

  6. flexibility

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

    Measured: baseline, 3-months and 6-months

  7. aerobic stamina

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

    Measured: baseline, 3-months and 6-months

  8. blood pressure

    change in blood pressure as measured by a blood pressure monitor

    Measured: baseline, 3-months and 6-months

  9. food cravings

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

    Measured: baseline, 3-months and 6-months

  10. happiness

    change in reported happiness as measured using the Oxford Happiness Questionnaire

    Measured: baseline, 3-months and 6-months

  11. sleep quality and duration: Pittsburgh Sleep Quality Index

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

    Measured: baseline, 3-months and 6-months

  12. 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)

    Measured: baseline, 3-months and 6-months

  13. subjective sensations of hunger

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

    Measured: baseline, 3-months and 6-months

  14. personal food assessment

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

    Measured: baseline and 6-months

  15. program satisfaction: WW generated satisfaction questionnaire

    program satisfaction as measured by the WW generated satisfaction questionnaire

    Measured: 3-months and 6-months

  16. health related quality of life: SF-36

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

    Measured: baseline, 3-months and 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study start18 Mar 2019
  3. Primary completion7 Nov 2019
  4. Study completion7 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This single-armed trial will have one condition: the modified WW Food program.
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03928483
Sponsor's protocol ID
Pro00085970
Status last verified
Dec 2019
First submitted
23 Apr 2019
Last updated
11 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Modified WW Food program in people with Obesity and Weight Loss, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body weight change (kg) (time frame: baseline to six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03928483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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