Promoting Healthy Exercise to Conscientious Christians

NCT06119334 | Unknown

• 1 other identifier: 3835
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019). This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention.

Conditions

Sedentary Behavior

Keywords

internet-based intervention with health coaching;

Outcome Measures

Primary Outcomes (5)

• International Physical Activity Questionnaire (IPAQ) (low-moderate-high)

  Self report of physical activity reflecting current activity

  Baseline

• International Physical Activity Questionnaire (IPAQ) (low-moderate-high)

  Change in self report of physical activity

  8 weeks

• International Physical Activity Questionnaire (IPAQ) (low-moderate-high)

  Change in self report of physical activity

  16 weeks

• Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.

  Electronic monitoring of steps

  8 weeks

• Fitbit Versa 2 Fitness Tracker connected to the NexJ Connected Wellness platform.

  Change in Electronic monitoring of steps

  16 weeks

Secondary Outcomes (16)

• Body Mass Index (BMI)

  Baseline

• Body Mass Index (BMI)

  16 weeks

• Patient Health Questionnaire-9 (PHQ - 9) (0-27)

  Baseline

• Patient Health Questionnaire-9 (PHQ - 9) (0-27)

  16 weeks

• General Anxiety Disorder-7 (GAD-7) (0-21)

  Baseline

Study Arms (2)

Experimental

EXPERIMENTAL

Sixteen weeks of phone-based counselling at a rate of 1 session/week and ongoing access to a online platform (Nex J Connected Wellness) that has health promotion text and videos readily accessed in combination with text messaging exchanges between counselor and participant. Participants receive a Fitbit which is connected to the Nex J Connected Wellness such that counselors can monitor steps/day.

Behavioral: Online intervention

Wait list control

NO INTERVENTION

Participants wait for 16 weeks.

Interventions

Online intervention BEHAVIORAL

Phone counselling for 1 hour/week over 16 weeks and access to the online platform with health promotion materials (videos, text, audios)

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (1) 25 to 55 years old; (2) self-identification as a regular church attendee (Lazerwitz, 1962); (3) willingness to complete the Big Five Inventory (BFI) (John et al., 2008; John \& Srivastava, 1999; (4) BFI scores that are 1 SD \> the mean score typically derived in most published studies; (5) willingness to receive and use a loaned Fitbit Versa 2 delivered by FedEx and commit to wearing it during daytime hours on a daily basis for the duration of the 16 week intervention (6) BMI between 27 and 33; (7) fluent in English; (8) approval from a primary care physician for initiating a graded-incremental walking exercise routine; (9) ability to walk for 30 minutes at a time without significant self-identification of pain and/or orthopedic dysfunction.

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University - School of Kinesiology and Health Science

Toronto, Ontario, M4E 3C1, Canada

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Paul G Ritvo, PhD

CONTACT

14165808021; pritvo@yorku.ca

Paul G Ritvo, PhD

CONTACT

4165808021; pritvo@yorku.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Paralell group design with intervention participants compared to wait-list control subjects. 16 weeks intervention.

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: November 7, 2023
• Study Start: November 25, 2023
• Primary Completion: November 10, 2025
• Study Completion: December 9, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2023-2025 - 2 years
• Access Criteria: all interested investigators

Locations

CA (1)