Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes

NCT06127251 | Completed

• 2 other identifiers: STUDY00006632P30DK111024
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The phenomenon of physical activity (PA) avoidance in obesity has been detailed in the literature, but there is a lack of programs designed to address the root causes. In addition to common PA barriers such as lack of time, individuals with obesity face weight-related impediments, including stigma, shame, poor fitness, and low exercise self-efficacy, which reduce their engagement in PA. These impediments have been observed in white and minoritized populations. Numerous studies have suggested that individuals with obesity prefer activities that are enjoyable, less exhausting, and conveniently available in settings where they are not exposed to stigma. The studies also point to a need for programs that focus on the general health benefits of PA rather than weight loss, which although desirable, can be elusive. Unmet weight loss expectations contribute to high dropout rates and non-adherence to the prescribed PA regimen among those with obesity. This is particularly consequential for minoritized populations including African Americans who tend to lose less weight in lifestyle interventions but achieve significant improvements in many cardiometabolic outcomes. In this proposal, investigators present PA as a buffer against the deleterious effects of obesity, agnostic of weight loss status. The Physical Activity for The Heart (PATH) program was intentionally designed to provide vicarious experiences for diverse individuals with obesity, by featuring their peers in body size, fitness level, and age engaging in PA. The impact of the PATH intervention on these biomarkers will provide important insights into the mechanisms via which a combination of popular PA modalities improves cardiometabolic outcomes in the context of obesity.

Conditions

Obesity

Keywords

Physical Activity; Workouts; Adipocytokines

Outcome Measures

Primary Outcomes (4)

• Attainment of recruitment goal

  Percentage of recruitment goal achieved within 4 months

  4 months after screening procedures start

• Participants' satisfaction of protocol procedures (acceptability)

  Satisfaction by participants will be measured with neutral messages/content collected via an end-of-study survey on user experience.

  12 weeks

• Adherence to protocol procedures

  Proportion of the sample who adhere to key study procedures (e.g., regular self-monitoring of PA, attendance of coaching sessions)

  12 weeks

• Retention Rate in each group

  Retention rate in each group at 12 weeks after enrollment

  12 weeks

Secondary Outcomes (4)

• Changes in adiponectin and leptin

  Baseline and 12 weeks

• Changes in Monocyte Chemoattractant Protein-1 (MCP-1)

  Baseline and 12 weeks

• Changes in proinflammatory cytokines

  Baseline and 12 weeks

• Changes in T2D risk score

  Baseline and 12 weeks

Other Outcomes (5)

• Change in exercise self-efficacy questionnaire (EXSE)

  Baseline and 12 weeks

• Change in exercise self-regulation

  Baseline and 12 weeks

• Change in the physical activity (PA) enjoyment

  Baseline and 12 weeks

Study Arms (2)

PATH Intervention

EXPERIMENTAL

Insufficiently active adults with obesity will be assigned to the PATH intervention.

Behavioral: PATH Intervention; Device: Physical activity tracker; Behavioral: Dietary education

Control Group

OTHER

Insufficiently active adults with obesity will be assigned to the attention control group.

Behavioral: Control Group; Device: Physical activity tracker; Behavioral: Dietary education

Interventions

PATH Intervention BEHAVIORAL

The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions on how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week. Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.

Also known as: PATH

PATH Intervention

Control Group BEHAVIORAL

Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.

Control Group

Physical activity tracker DEVICE

Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.

Also known as: ScanWatch

Control Group; PATH Intervention

Dietary education BEHAVIORAL

The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks

Control Group; PATH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years, body mass index (BMI) ≥30kg/m2,
• regular access to the Internet,
• self-monitoring of PA via waist worn Actigraph during run-in (≥4 days with ≥10hrs wear time),
• self-reported non-adherence to PA Guidelines \[\<150 min of moderate to vigorous physical activities (MVPA/wk)\].

You may not qualify if:

• pregnancy/intention to become pregnant within 12 weeks,
• involvement in litigation related to a health issue, or a condition that requires supervised PA (e.g., stroke).
• Individuals with a history of cerebrovascular disease (CVD), type 2 diabetes (T2D),
• any affirmative response to any question in the Physical Activity Readiness Questionnaire (PAR-Q) will require primary care physician (PCP) clearance before enrollment.

Sponsors & Collaborators

• Emory University: lead
• Georgia Center for Diabetes Translation Research: collaborator
• American Diabetes Association: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Control Groups; Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jacob Kariuki, PhD, NP

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: April 11, 2024
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing one year after the publication of the study outcomes. Start date December 2025, end date 2032
• Access Criteria: Individual participant data will be available for sharing with researchers for secondary analysis. The request should be directed to jacob.kariuki@emory.edu. Requesters will need to sign a data access agreement. Data will be shared via OneDrive.

Locations

US (1)