Neurocognitive Benefits of a Weight Management Program

NCT04202133 | Completed Phase 4 Results DMC

• 1 other identifier: 834404
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight and Obesity

Keywords

obesity; weight loss; neuroimaging; fMRI; behavioral obesity treatment

Outcome Measures

Primary Outcomes (8)

• 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

  Change from baseline to 16 weeks

• Reward-based Eating

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

  Change from baseline to 16 weeks

• 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

  Change from baseline to 16 weeks

• Food Preference

  Changes in scores on the Leeds Food Preference Questionnaire

  Change from baseline to 16 weeks

• 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

  Change from baseline to 16 weeks

• Hippocampal Volume

  Change in hippocampal volume

  Change from baseline to 16 weeks

• BOLD fMRI Response to the N-back Task

  Changes in BOLD fMRI response to the N-back task

  Change from baseline to 16 weeks

• 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

  Change from baseline to 16 weeks

Secondary Outcomes (4)

• N-back Behavioral Performance

  Change from baseline to 16 weeks

• Percent Weight

  Change from baseline to 16 weeks

• Eating Behavior

  Change from baseline to 16 weeks

• Power of Food

  Change from baseline to 16 weeks

Study Arms (2)

WW (formerly Weight Watchers)

EXPERIMENTAL

16-weeks of the group-based WW program

Behavioral: WW (formerly Weight Watchers)

Waitlist Control

OTHER

16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program

Behavioral: Waitlist

Interventions

WW (formerly Weight Watchers) BEHAVIORAL

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

WW (formerly Weight Watchers)

Waitlist BEHAVIORAL

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

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-60 years
• Female
• BMI\>30 kg/m2
• Eligible female patients will be:
• Non-pregnant
• Non-lactating
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• WW International Inc: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 37916843 DERIVED

• 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.

  PMID: 37156318 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Ariana Chao
• Organization: University of Pennsylvanai

arichao@upenn.edu

215-746-7183

Study Officials

• Ariana M. Chao, PhD, CRNP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 17, 2019
• Study Start: November 20, 2019
• Primary Completion: April 2, 2021
• Study Completion: July 20, 2021
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Locations

US (1)