The Kickstart Health Program

Health Behavior Clinical Trial

Official title:

Acceptability and Feasibility of a Multicomponent Group Intervention to Initiate Health Behavior Change: The Kickstart Health Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308162
• Other study ID #: 2017-270
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing the acceptability and feasibility of an active, experiential group therapy for health behavior change within a medical setting.

Description:

The purpose of the current study is to offer a preliminary test of feasibility and acceptability for a group intervention, conducted in a primary care setting, that aims to teach skills that initiate health behavior change. Participants will be recruited from a local family medicine clinic and groups will be held on site at the clinic. Patients will be recruited by their physicians and given a baseline survey of their exercise and nutrition behaviors as well as their overall well being and self efficacy to change their health behaviors. Participants can join the group at any time and attend as many sessions as desired. Groups are held 2 times per month and include worksheets, meditations, and exercise. Patients and their providers will be given 2 follow up surveys after 5 and 13 weeks to assess for acceptability and feasibility of the program, as well as health behavior change. Statistical analyses will include multivariate analyses, descriptive analyses, and frequency data collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A patient of the Beaumont Family Medicine Center - Troy/Sterling Heights

• Access to a computer or electronic device with an internet browser

• Internet connectivity

• Patient verbally confirms during recruitment phone call that they can independently or with minimal assistance complete online surveys

• English speaking

Exclusion Criteria:

• Individuals who do not have regular access to internet connectivity

• Not approved by their physician to complete the group exercises

• Denies the ability to fill out online surveys with minimal assistance

• Non-English speaking

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Cognitive behavioral experiential group therapy
The Kickstart Health Program is a Cognitive-Behavioral Experiential Therapy (CBET) that is administered via a person-centered group therapy format. Participants receive multiple therapeutic components that include psychoeducation, cognitive behavioral therapy, motivational interviewing, mindfulness, and acceptance and commitment therapy. Participants will also meditate and exercise in the group.

Locations

Country	Name	City	State
United States	Beaumont Family Medicine	Sterling Heights	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Blue Cross Blue Shield of Michigan Foundation, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and feasibility	Survey measure of acceptability and feasibility of the novel study in a health care setting	5 weeks
Primary	Change in acceptability and feasibility from 5 weeks	Survey measure of a change in acceptability and feasibility of the novel study in a health care setting	13 weeks
Secondary	Personal Medical History Questionnaire	Measure of relevant medical history	Baseline
Secondary	Health Specific Self Efficacy Scales	Measure of one's belief that one can engage in health behavior and it is important	Baseline
Secondary	Change in health specific self efficacy from baseline	Measure of one's belief that one can engage in health behavior and it is important	5-weeks
Secondary	Change in health specific self efficacy from 5-weeks	Measure of one's belief that one can engage in health behavior and it is important	13-weeks
Secondary	Exercise Beliefs and Benefits Scale (EBBS)	Measure of one's belief that one can engage in exercise and it is important	Baseline, 5-, and 13-weeks
Secondary	Change in exercise Beliefs and Benefits Scale (EBBS) from baseline	Measure of one's belief that one can engage in exercise and it is important	5-weeks
Secondary	Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks	Measure of one's belief that one can engage in exercise and it is important	13-weeks
Secondary	Short Form 8 (SF-8)	Measure of subjective health	Baseline, 5-, and 13-weeks
Secondary	Change in SF-8 from baseline	Measure of subjective health	5-weeks
Secondary	Change in SF-8 from 5 weeks	Measure of subjective health	13-weeks
Secondary	International Physical Activity Questionnaire (IPAQ)	Measure of weekly physical activity	Baseline, 5-, and 13-weeks
Secondary	Change in International Physical Activity Questionnaire (IPAQ) from baseline	Measure of weekly physical activity	5-weeks
Secondary	Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks	Measure of weekly physical activity	13-weeks
Secondary	Simple Food Frequency Questionnaire (S-FFQ)	Measure of food consumption across different food groups	Baseline
Secondary	Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline	Measure of food consumption across different food groups	5-weeks
Secondary	Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks	Measure of food consumption across different food groups	13-weeks
Secondary	Satisfaction with Life Scale (SWL)	Measure of overall well being	Baseline, 5-, and 13-weeks
Secondary	Change in Satisfaction with Life Scale (SWL) from baseline	Measure of overall well being	5-weeks
Secondary	Change in Satisfaction with Life Scale (SWL) from 5-weeks	Measure of overall well being	13-weeks
Secondary	The Group Attitude Scale	Measure of group cohesion	5-weeks
Secondary	Change in The Group Attitude Scale from 5-weeks	Measure of group cohesion	13-weeks
Secondary	Height	Measure of self reported high	Baseline
Secondary	Weight	Measure of self reported weight	Baseline
Secondary	Change in weight from baseline	Measure of self reported weight	5-weeks
Secondary	Change in weight from 5-weeks	Measure of self reported weight	13-weeks
Secondary	Average daily steps	Measure of self reported average daily steps	Baseline
Secondary	Change in average daily steps from baseline	Measure of self reported average daily steps	5-weeks
Secondary	Change in average daily steps from 5-weeks	Measure of self reported average daily steps	13-weeks