Clinical trial NCT03308162: The Kickstart Health Program
Official title: Acceptability and Feasibility of a Multicomponent Group Intervention to Initiate Health Behavior Change: The Kickstart Health Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Integrated Behavioral Health Care
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Wayne State University
name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2017-10-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within subjects repeated measures
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability and feasibility
timeFrame: 5 weeks
measure: Change in acceptability and feasibility from 5 weeks
timeFrame: 13 weeks
Secondary outcomes:
measure: Personal Medical History Questionnaire
timeFrame: Baseline
measure: Health Specific Self Efficacy Scales
timeFrame: Baseline
measure: Change in health specific self efficacy from baseline
timeFrame: 5-weeks
measure: Change in health specific self efficacy from 5-weeks
timeFrame: 13-weeks
measure: Exercise Beliefs and Benefits Scale (EBBS)
timeFrame: Baseline, 5-, and 13-weeks
measure: Change in exercise Beliefs and Benefits Scale (EBBS) from baseline
timeFrame: 5-weeks
measure: Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks
timeFrame: 13-weeks
measure: Short Form 8 (SF-8)
timeFrame: Baseline, 5-, and 13-weeks
measure: Change in SF-8 from baseline
timeFrame: 5-weeks
measure: Change in SF-8 from 5 weeks
timeFrame: 13-weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 5-, and 13-weeks
measure: Change in International Physical Activity Questionnaire (IPAQ) from baseline
timeFrame: 5-weeks
measure: Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks
timeFrame: 13-weeks
measure: Simple Food Frequency Questionnaire (S-FFQ)
timeFrame: Baseline
measure: Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline
timeFrame: 5-weeks
measure: Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks
timeFrame: 13-weeks
measure: Satisfaction with Life Scale (SWL)
timeFrame: Baseline, 5-, and 13-weeks
measure: Change in Satisfaction with Life Scale (SWL) from baseline
timeFrame: 5-weeks
measure: Change in Satisfaction with Life Scale (SWL) from 5-weeks
timeFrame: 13-weeks
measure: The Group Attitude Scale
timeFrame: 5-weeks
measure: Change in The Group Attitude Scale from 5-weeks
timeFrame: 13-weeks
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Change in weight from baseline
timeFrame: 5-weeks
measure: Change in weight from 5-weeks
timeFrame: 13-weeks
measure: Average daily steps
timeFrame: Baseline
measure: Change in average daily steps from baseline
timeFrame: 5-weeks
measure: Change in average daily steps from 5-weeks
timeFrame: 13-weeks
Other outcomes:
Locations:
city: Sterling Heights
country: United States
facility: Beaumont Family Medicine
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Lori Lackman-Zeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: