- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308162
The Kickstart Health Program
September 25, 2018 updated by: Lackman-Zeman, Lori A, PhD, William Beaumont Hospitals
Acceptability and Feasibility of a Multicomponent Group Intervention to Initiate Health Behavior Change: The Kickstart Health Program
This study is testing the acceptability and feasibility of an active, experiential group therapy for health behavior change within a medical setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Sterling Heights, Michigan, United States, 48314
- Beaumont Family Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Intervention
Cognitive behavioral experiential group therapy for health behavior change
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability and feasibility
Time Frame: 5 weeks
|
Survey measure of acceptability and feasibility of the novel study in a health care setting
|
5 weeks
|
|
Change in acceptability and feasibility from 5 weeks
Time Frame: 13 weeks
|
Survey measure of a change in acceptability and feasibility of the novel study in a health care setting
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Medical History Questionnaire
Time Frame: Baseline
|
Measure of relevant medical history
|
Baseline
|
|
Health Specific Self Efficacy Scales
Time Frame: Baseline
|
Measure of one's belief that one can engage in health behavior and it is important
|
Baseline
|
|
Change in health specific self efficacy from baseline
Time Frame: 5-weeks
|
Measure of one's belief that one can engage in health behavior and it is important
|
5-weeks
|
|
Change in health specific self efficacy from 5-weeks
Time Frame: 13-weeks
|
Measure of one's belief that one can engage in health behavior and it is important
|
13-weeks
|
|
Exercise Beliefs and Benefits Scale (EBBS)
Time Frame: Baseline, 5-, and 13-weeks
|
Measure of one's belief that one can engage in exercise and it is important
|
Baseline, 5-, and 13-weeks
|
|
Change in exercise Beliefs and Benefits Scale (EBBS) from baseline
Time Frame: 5-weeks
|
Measure of one's belief that one can engage in exercise and it is important
|
5-weeks
|
|
Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks
Time Frame: 13-weeks
|
Measure of one's belief that one can engage in exercise and it is important
|
13-weeks
|
|
Short Form 8 (SF-8)
Time Frame: Baseline, 5-, and 13-weeks
|
Measure of subjective health
|
Baseline, 5-, and 13-weeks
|
|
Change in SF-8 from baseline
Time Frame: 5-weeks
|
Measure of subjective health
|
5-weeks
|
|
Change in SF-8 from 5 weeks
Time Frame: 13-weeks
|
Measure of subjective health
|
13-weeks
|
|
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, 5-, and 13-weeks
|
Measure of weekly physical activity
|
Baseline, 5-, and 13-weeks
|
|
Change in International Physical Activity Questionnaire (IPAQ) from baseline
Time Frame: 5-weeks
|
Measure of weekly physical activity
|
5-weeks
|
|
Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks
Time Frame: 13-weeks
|
Measure of weekly physical activity
|
13-weeks
|
|
Simple Food Frequency Questionnaire (S-FFQ)
Time Frame: Baseline
|
Measure of food consumption across different food groups
|
Baseline
|
|
Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline
Time Frame: 5-weeks
|
Measure of food consumption across different food groups
|
5-weeks
|
|
Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks
Time Frame: 13-weeks
|
Measure of food consumption across different food groups
|
13-weeks
|
|
Satisfaction with Life Scale (SWL)
Time Frame: Baseline, 5-, and 13-weeks
|
Measure of overall well being
|
Baseline, 5-, and 13-weeks
|
|
Change in Satisfaction with Life Scale (SWL) from baseline
Time Frame: 5-weeks
|
Measure of overall well being
|
5-weeks
|
|
Change in Satisfaction with Life Scale (SWL) from 5-weeks
Time Frame: 13-weeks
|
Measure of overall well being
|
13-weeks
|
|
The Group Attitude Scale
Time Frame: 5-weeks
|
Measure of group cohesion
|
5-weeks
|
|
Change in The Group Attitude Scale from 5-weeks
Time Frame: 13-weeks
|
Measure of group cohesion
|
13-weeks
|
|
Height
Time Frame: Baseline
|
Measure of self reported high
|
Baseline
|
|
Weight
Time Frame: Baseline
|
Measure of self reported weight
|
Baseline
|
|
Change in weight from baseline
Time Frame: 5-weeks
|
Measure of self reported weight
|
5-weeks
|
|
Change in weight from 5-weeks
Time Frame: 13-weeks
|
Measure of self reported weight
|
13-weeks
|
|
Average daily steps
Time Frame: Baseline
|
Measure of self reported average daily steps
|
Baseline
|
|
Change in average daily steps from baseline
Time Frame: 5-weeks
|
Measure of self reported average daily steps
|
5-weeks
|
|
Change in average daily steps from 5-weeks
Time Frame: 13-weeks
|
Measure of self reported average daily steps
|
13-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lori Lackman-Zeman, PhD, William Beaumont Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2017
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
October 3, 2017
First Submitted That Met QC Criteria
October 6, 2017
First Posted (Actual)
October 12, 2017
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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