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Overweight and ObesityPhase 4NCT04202133

Neurocognitive Benefits of a Weight Management Program

A Phase 4 study testing WW (formerly Weight Watchers) and Waitlist in people with Overweight and Obesity, run by University of Pennsylvania 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

This study will assess whether weight loss induced through diet and physical activity can change neural responses to high- and low-calorie food images. In addition, it will evaluate whether weight loss can improve neural function when performing the N-back task, a measure of working memory. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
WW (formerly Weight Watchers) and Waitlist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
20 Nov 2019to 20 Jul 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-60 years
  • Female
  • BMI>30 kg/m2
  • Eligible female patients will be:
  • Non-pregnant
  • Non-lactating
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  • Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses).
  • Participants must:
  • Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

Who cannot join

  • Weight>158.8 kg (350 lbs, due to scanner weight restrictions)
  • Serious medical risk such as type 1 or 2 diabetes, cancer, or recent cardiac event (e.g., heart attack, angioplasty)
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
  • Current psychiatric disorder that significantly interferes with daily living
  • Active suicidal ideation
  • Current substance use disorder (current or in remission < 1 year)
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  • Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
  • Participation in a structured weight loss program in the prior 6 months
  • WW member within the past 12 months
  • Use of medications known to induce significant weight loss/gain, including chronic use of oral steroids in the past 3 months
  • Psychiatric hospitalization within the past 6 months
  • Loss of >10 lbs of body weight within the past 3 months
  • History or plans for bariatric surgery
  • Visual, auditory, or other impairment affecting task performance
  • Epilepsy
  • Neurological trauma (e.g., concussion)
  • Inability to attend treatment and/or assessment visits
  • Participant from same household
  • Adherence to specialized diet regimes, such as vegetarian, macrobiotic
  • Lack of capacity to provide informed consent
  • Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
  • Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program

This study will assess whether weight loss induced through diet and physical activity can change neural responses to high- and low-calorie food images. In addition, it will evaluate whether weight loss can improve neural function when performing the N-back task, a measure of working memory. Findings will address notable gaps in the literature by testing whether a scalable weight loss intervention can help protect and improve neurocognitive functioning and brain health in individuals with obesity. This study will also provide important information about the effects of weight loss on neuroplasticity in brain regions crucial for memory and cognitive functioning, which will help to inform future interventions aimed at promoting brain health.

Read the detailed description

The purpose of the present study is to conduct a randomized controlled trial (RCT) to assess the effects of a commercially available weight loss program (WW; formerly Weight Watchers) on neural response to food cues and memory tasks, as well as on structural brain morphology. Participants with obesity will be randomized to either 16 weeks of an in-person, group-based WW program (n=30) or a wait-list control (WLC; n=30). Both groups will have structural and blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. Participants will complete the following fMRI tasks: 1) structural scan; 2) food cue task to measure reactivity to high and low-calorie food images and 3) N-back task to measure working memory (i.e., the ability to temporarily hold information available for processing). In addition, participants will complete self-report and behavioral measures of eating behaviors, appetite, physical activity, mood, quality of life, attention and memory at baseline, and weeks 8 and 16.

Being tested
WW (formerly Weight Watchers), Waitlist
Keywords
obesity, weight loss, neuroimaging, fMRI, behavioral obesity treatment
Medical subject headings
Overweight, Obesity, Weight Loss

What participants receive

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

  • WW (formerly Weight Watchers)Behavioural

    The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.

  • WaitlistBehavioural

    The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention

Study groups in NCT04202133
Study groupRoleWhat they receive
WW (formerly Weight Watchers)Experimental16-weeks of the group-based WW program
Receives: Behavioral: WW (formerly Weight Watchers)
Waitlist ControlOther16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program
Receives: Behavioral: Waitlist

What is being measured

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

  1. Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex

    Changes in BOLD fMRI response to high-calorie food images

    Measured: Change from baseline to 16 weeks

  2. Reward-based Eating

    Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating

    Measured: Change from baseline to 16 weeks

  3. Food Cravings- Trait (Lack of Control Over Eating)

    Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings

    Measured: Change from baseline to 16 weeks

  4. Food Preference

    Changes in scores on the Leeds Food Preference Questionnaire

    Measured: Change from baseline to 16 weeks

  5. Eating Behaviors

    Changes in scores on the Eating Behaviors Questionnaire (liking for high-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a worse outcome

    Measured: Change from baseline to 16 weeks

  6. Hippocampal Volume

    Change in hippocampal volume

    Measured: Change from baseline to 16 weeks

  7. BOLD fMRI Response to the N-back Task

    Changes in BOLD fMRI response to the N-back task

    Measured: Change from baseline to 16 weeks

  8. Eating Behaviors (Low-calorie Foods)

    Changes in scores on the Eating Behaviors Questionnaire (liking for low-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a better outcome

    Measured: Change from baseline to 16 weeks

Secondary outcomes (4)

  1. N-back Behavioral Performance

    Change in reaction time (seconds) on the N-back task

    Measured: Change from baseline to 16 weeks

  2. Percent Weight

    Percent weight change

    Measured: Change from baseline to 16 weeks

  3. Eating Behavior

    Changes in eating behavior as measured by the Eating Inventory (Cognitive restraint, disinhibited eating, and hunger subscales, summed scores, higher values indicate greater restraint/disinhibition/hunger). The cognitive restraint scale includes 21 items (range 0-21). Higher scores demonstrate more awareness of one's eating and success in restricting dietary intake for weight control. The disinhibited eating scale includes 16 items (range 0-16). Higher scores signify more overeating tendencies. The hunger scale has 14 items and higher scores indicate more perceived hunger (range 0-14). Subscales were analyzed separately.

    Measured: Change from baseline to 16 weeks

  4. Power of Food

    Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger. Range of scores is 1-5

    Measured: Change from baseline to 16 weeks

Timeline

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

  1. First posted17 Dec 2019
  2. Study start20 Nov 2019
  3. Primary completion2 Apr 2021
  4. Study completion20 Jul 2021

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
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202133
Sponsor's protocol ID
834404
Status last verified
Jan 2025
First submitted
3 Dec 2019
Last updated
10 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chao AM, Wadden TA, Cao W, Zhou Y, Maldonado D, Cardel MI, Foster GD, Loughead J. Randomized Controlled Trial of Effects of Behavioral Weight Loss Treatment on Food Cue Reactivity. Nurs Res. 2024 Mar-Apr 01;73(2):91-100. doi: 10.1097/NNR.0000000000000702. Epub 2023 Oct 31.

    PubMed 37916843

  • Chao AM, Zhou Y, Erus G, Davatzikos C, Cardel MI, Foster GD, Wadden TA. A randomized controlled trial examining the effects of behavioral weight loss treatment on hippocampal volume and neurocognition. Physiol Behav. 2023 Aug 1;267:114228. doi: 10.1016/j.physbeh.2023.114228. Epub 2023 May 6.

    PubMed 37156318

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing WW (formerly Weight Watchers) and Waitlist in people with Overweight and Obesity, run by University of Pennsylvania 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 9 inclusion and 22 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 10 Feb 2025. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex (time frame: Change from baseline to 16 weeks). The study lists 8 primary outcomes in all. 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 NCT04202133, which also lists 2 linked publications.

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 10 Feb 2025.

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