Team Science to Promote Physical Activity

Status Completed

Clinical Trial Summary

Background: Fun For Wellness is an online intervention designed to promote growth in well-being and physical activity by providing confidence-enhancing learning opportunities to participants.

Objective: The objective of this feasibility study is to address uncertainties regarding the inclusion of accelerometer-based assessment of physical activity within the Fun For Wellness online intervention among free-living adults with obesity in the United States of America.

Method: The study design is a prospective, double-blind, parallel group randomized pilot trial.

Discussion: Results are intended to inform the preparation of a future definitive randomized controlled trial.

Clinical Trial Description

Fun For Wellness is an online intervention designed to promote growth in well-being and physical activity by providing confidence-enhancing learning opportunities to participants [1]. The conceptual framework for the Fun For Wellness intervention is guided by self-efficacy theory [2]. Evidence has been provided for the efficacy of Fun For Wellness to promote self-reported physical well-being actions in free-living adults who comply with the intervention [3]. The objective of this feasibility study is to address uncertainties regarding the inclusion of accelerometer-based assessment of physical activity within the Fun For Wellness online intervention among free-living adults with obesity in the United States of America.

Four specific aims will be investigated. Aim 1. To determine if accelerometer-based assessment of physical activity can be used within the Fun For Wellness intervention.

Aim 2. To determine if accelerometer-based assessment of physical activity should be used within the Fun For Wellness intervention.

Aim 3. To determine how to implement accelerometer-based assessment of physical activity within the Fun For Wellness intervention.

Aim 4. To provide a preliminary effect size estimate for each direct effect in the conceptual model for the Fun For Wellness online intervention.

Pursuit of these four specific aims is based on a general conceptual framework for feasibility and pilot studies in preparation for a future definitive randomized controlled trial [4-6]. Within this conceptual framework, a randomized pilot trial is a type of a feasibility study and a feasibility study may include a focus on the acceptability of an intervention [4-6]. ;

Study Design

Related Conditions & MeSH terms

Health Promotion

Clinical Trial Details

NCT number	NCT03906942
Study type	Interventional
Source	Michigan State University
Contact
Status	Completed
Phase	N/A
Start date	November 7, 2019
Completion date	April 2, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.