Clinical Trials Directory

Trials / Completed

CompletedNCT03906942

Team Science to Promote Physical Activity

Using Team Science to Promote Health-Enhancing Physical Activity in Adults With Obesity in a Community Setting: A Feasibility Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

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.

Detailed 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 \[4-6\].

Conditions

Interventions

TypeNameDescription
BEHAVIORALFun For Wellness (FFW)FFW consists of videos, games, and content in the form of 152 BET I CAN challenges \[1\]. Behavior challenges are intended to increase a participant's capabilities to set a goal and to create positive habits. Emotion challenges are intended to increase a participant's capabilities to cope with negative emotions and to cultivate positive emotions. Thought challenges are intended to increase a participant's capabilities to challenge negative assumptions and to create a new narrative for their life. Interaction challenges are intended to increase a participant's capabilities to communicate and connect with others. Context challenges are intended to increase a participant's capabilities to read cues and to change cues in the environment. Awareness challenges are intended to increase a participant's capabilities to know herself/himself and to know the issue. Next steps challenges are intended to increase a participant's capabilities to make a plan and to stick with a plan.

Timeline

Start date
2019-11-07
Primary completion
2020-04-02
Completion
2020-04-02
First posted
2019-04-08
Last updated
2020-09-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03906942. Inclusion in this directory is not an endorsement.