NCT07095673

Brief Summary

The goal of this project was to reduce and manage obesity and increase self-efficacy for keeping a healthy weight and improve pain, quality of life, and mental health symptoms among 60 adults aged 19 and older in Camden City, New Jersey. The City of Camden has an adult obesity rate of 44.1%. Obesity and aging are significant contributing factors to increased utilizations of healthcare services. Obesity is a major risk factor for non-communicable illnesses such as cardiovascular disease, type 2 diabetes, hypertension, dyslipidemia, pain, and mental health. Physical activity is effective in reducing and managing obesity. However, personal barriers (e.g., lack of time for physical activity, physical capability to perform physical activities, competing demands), built environment (e.g., safe spaces for physical activities), climate changes (e.g., heat waves and extreme weather which prevent outdoor physical activities), and systematic barriers (e.g., intervention availability) hamper obesity prevention and management in older adult population. To help older adults keep a healthy weight, our team has adapted and delivered the effective person-centered integrative interventions: HealthyWE: Keeping a Healthy Weight program to older adults in Camden New Jersey. Completion of the project will build a strong community capacity in Camden to sustain a community effort to reduce obesity and pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

July 9, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

obesity reductionself-efficacyexercise interventionlow-income communityintegrative strategies

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    A stand-on bioimpedance analysis (BIA) device (InBody 520, Biospace Co., Ltd., Cerritos, CA, USA) is used to automatically calculate BMI (kilogram/meters squared, kg/m2). Obesity is defined as a BMI\>30 kg/m2. The Inbody 520 multifrequency BIA device is also used to measure body fat percentage, and body fat mass using impedance at 5, 50, and 500 kHz.

    3 intervals: baseline, 6-week follow up and 14-week follow up.

Secondary Outcomes (3)

  • Pain Severity and Interference

    3 intervals: baseline, 6-week follow up and 14-week follow up.

  • Quality of Life (PROMIS GHS)

    baseline, 6-week follow up and 14-week follow up.

  • Mental Health Symptoms

    baseline, 6-week follow up and 14-week follow up.

Other Outcomes (1)

  • Self-efficacy for Achieving a Healthy Weight

    baseline, 6-week follow up and 14-week follow up.

Study Arms (1)

Healthy WE

OTHER

Sixty (60) adults residing in the Housing Authority of the City of Camden will be recruited to be engaged in HealthyWE program to be completed in 4 weekly coaching sessions. Treatment adherence refers to the extent to which interventions are delivered as prescribed

Behavioral: HealthyWE

Interventions

HealthyWEBEHAVIORAL

Following baseline assessment, 60 residents will be enrolled in HealthyWE Corps program. HealthyWE Corps includes training sessions on keeping a healthy weight, healthy diet, and mental health wellness. The content of the HealthyWE protocol was carefully designed choosing skills shown to be efficacious in keeping a healthy weight and reducing pain. Self-efficacy theory guides the intervention. Behavioral interventions for reducing and managing obesity focus on building adults' self-management skills to be implemented in their daily lives. To achieve the therapeutic effects, individuals have to execute self-management skills in their daily lives. Self-efficacy is defined as a person's belief in his/her ability to perform specific skills to reduce and manage obesity.

Healthy WE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over the age of 19
  • BMI of \> 25

You may not qualify if:

  • Adults with BMI of less than 25
  • Adults who are not active:
  • with activity participation limitations
  • with disability (physical, mental)
  • impairment (vision, hearing and memory loss, cognitive)
  • dementia
  • Alzheimer's disease (AD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing Camden

Camden, New Jersey, 08108, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas A Dahan, PhD

    Rutgers, the State University of NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 31, 2025

Study Start

June 20, 2023

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Immediately following publication with no end data.
Access Criteria
Anyone who wishes to access the data for any purpose.

Locations