Team Science to Promote Physical Activity

Michigan State University

Status: Completed

Conditions: Health Promotion

Treatments: Behavioral: Fun For Wellness (FFW)

Study type: Interventional

Funder types: Other

Identifiers

NCT03906942

STUDY00002012

Details and patient eligibility

About

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.

Full 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].

Enrollment: 33 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individual is at least 18 years old but not older than 64 years old. Individual has a body mass index (BMI) ≥ 25.00 kg/m2. Individual has access to a technological device (e.g., computer) that can access the online intervention.

Individual is not simultaneously enrolled in another program promoting either well-being or physical activity.

Individual is willing to comply with instructions for physical activity monitoring.

Exclusion criteria

Individual is less than 18 years old or older than 64 years old. Individual has a body mass index (BMI) < 25.00. Individual does not have access to a technological device (e.g., computer) that can access the online intervention.

Individual is simultaneously enrolled in another program promoting either well-being or physical activity.

Individual is unwilling to comply with instructions for physical activity monitoring.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups

Fun For Wellness (FFW)

Experimental group

Description:

Participants assigned to the FFW group (i.e., FFW participants) will proceed through the pre-operative program provided by the center and will be given 4 weeks of 24 hr access to the FFW online intervention during data collection for this study. Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being and/or physical activity.

Treatment:

Behavioral: Fun For Wellness (FFW)

Usual Care (UC)

No Intervention group

Description:

Participants assigned to the UC group (i.e., UC participants) will proceed through the pre-operative weight management program provided by the center.