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Completed

NCT Number: NCT03308162

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.

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Key information

Conditions

Health Behavior Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Family Medicine

Sterling Heights, Michigan, 48314, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral experiential group therapy

Behavioral

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: Kickstart Health

Primary outcomes

  1. Acceptability and feasibility

    Time frame: 5 weeks

    Survey measure of acceptability and feasibility of the novel study in a health care setting

  2. 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

Secondary outcomes

  1. Personal Medical History Questionnaire

    Time frame: Baseline

    Measure of relevant medical history

  2. Health Specific Self Efficacy Scales

    Time frame: Baseline

    Measure of one's belief that one can engage in health behavior and it is important

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Short Form 8 (SF-8)

    Time frame: Baseline, 5-, and 13-weeks

    Measure of subjective health

  9. Change in SF-8 from baseline

    Time frame: 5-weeks

    Measure of subjective health

  10. Change in SF-8 from 5 weeks

    Time frame: 13-weeks

    Measure of subjective health

  11. International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline, 5-, and 13-weeks

    Measure of weekly physical activity

  12. Change in International Physical Activity Questionnaire (IPAQ) from baseline

    Time frame: 5-weeks

    Measure of weekly physical activity

  13. Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks

    Time frame: 13-weeks

    Measure of weekly physical activity

  14. Simple Food Frequency Questionnaire (S-FFQ)

    Time frame: Baseline

    Measure of food consumption across different food groups

  15. Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline

    Time frame: 5-weeks

    Measure of food consumption across different food groups

  16. Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks

    Time frame: 13-weeks

    Measure of food consumption across different food groups

  17. Satisfaction with Life Scale (SWL)

    Time frame: Baseline, 5-, and 13-weeks

    Measure of overall well being

  18. Change in Satisfaction with Life Scale (SWL) from baseline

    Time frame: 5-weeks

    Measure of overall well being

  19. Change in Satisfaction with Life Scale (SWL) from 5-weeks

    Time frame: 13-weeks

    Measure of overall well being

  20. The Group Attitude Scale

    Time frame: 5-weeks

    Measure of group cohesion

  21. Change in The Group Attitude Scale from 5-weeks

    Time frame: 13-weeks

    Measure of group cohesion

  22. Height

    Time frame: Baseline

    Measure of self reported high

  23. Weight

    Time frame: Baseline

    Measure of self reported weight

  24. Change in weight from baseline

    Time frame: 5-weeks

    Measure of self reported weight

  25. Change in weight from 5-weeks

    Time frame: 13-weeks

    Measure of self reported weight

  26. Average daily steps

    Time frame: Baseline

    Measure of self reported average daily steps

  27. Change in average daily steps from baseline

    Time frame: 5-weeks

    Measure of self reported average daily steps

  28. Change in average daily steps from 5-weeks

    Time frame: 13-weeks

    Measure of self reported average daily steps

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation
  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2017
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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