CClinicalTrials.gg
CompletedNCT03308162Updated Sep 26, 2018

The Kickstart Health Program

An interventional study of Cognitive behavioral experiential group therapy in Health Behavior, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Health Behavior

Keywords

  • Integrated Behavioral Health Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Group Intervention

    Cognitive behavioral experiential group therapy for health behavior change

    Behavioral: Cognitive behavioral experiential group therapy

Interventions

  • BehavioralCognitive 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.

    Also known as: Kickstart Health

05

What researchers measure

Primary outcomes

  1. Acceptability and feasibility

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

    Time frame: 5 weeks

  2. 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

    Time frame: 13 weeks

Secondary outcomes

  1. Personal Medical History Questionnaire

    Measure of relevant medical history

    Time frame: Baseline

  2. Health Specific Self Efficacy Scales

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

    Time frame: Baseline

  3. Change in health specific self efficacy from baseline

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

    Time frame: 5-weeks

  4. 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

    Time frame: 13-weeks

  5. Exercise Beliefs and Benefits Scale (EBBS)

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

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

  6. 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

    Time frame: 5-weeks

  7. 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

    Time frame: 13-weeks

  8. Short Form 8 (SF-8)

    Measure of subjective health

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

  9. Change in SF-8 from baseline

    Measure of subjective health

    Time frame: 5-weeks

  10. Change in SF-8 from 5 weeks

    Measure of subjective health

    Time frame: 13-weeks

  11. International Physical Activity Questionnaire (IPAQ)

    Measure of weekly physical activity

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

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

    Measure of weekly physical activity

    Time frame: 5-weeks

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

    Measure of weekly physical activity

    Time frame: 13-weeks

  14. Simple Food Frequency Questionnaire (S-FFQ)

    Measure of food consumption across different food groups

    Time frame: Baseline

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

    Measure of food consumption across different food groups

    Time frame: 5-weeks

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

    Measure of food consumption across different food groups

    Time frame: 13-weeks

  17. Satisfaction with Life Scale (SWL)

    Measure of overall well being

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

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

    Measure of overall well being

    Time frame: 5-weeks

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

    Measure of overall well being

    Time frame: 13-weeks

  20. The Group Attitude Scale

    Measure of group cohesion

    Time frame: 5-weeks

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

    Measure of group cohesion

    Time frame: 13-weeks

  22. Height

    Measure of self reported high

    Time frame: Baseline

  23. Weight

    Measure of self reported weight

    Time frame: Baseline

  24. Change in weight from baseline

    Measure of self reported weight

    Time frame: 5-weeks

  25. Change in weight from 5-weeks

    Measure of self reported weight

    Time frame: 13-weeks

  26. Average daily steps

    Measure of self reported average daily steps

    Time frame: Baseline

  27. Change in average daily steps from baseline

    Measure of self reported average daily steps

    Time frame: 5-weeks

  28. Change in average daily steps from 5-weeks

    Measure of self reported average daily steps

    Time frame: 13-weeks

06

Study locations

1 site
  • Beaumont Family Medicine
    Sterling Heights, Michigan 48314, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03308162
Lead sponsor
William Beaumont Hospitals
Collaborators
Wayne State University, Blue Cross Blue Shield of Michigan Foundation
Responsible party
Lackman-Zeman, Lori A, PhD (Principal Investigator, William Beaumont Hospitals) — Principal investigator
First posted
Oct 12, 2017
Start date
Oct 10, 2017
Primary completion
Jul 31, 2018
Completion
Aug 31, 2018
Last update
Sep 26, 2018

Study contacts

Lori Lackman-Zeman, PhD
principal investigator · William Beaumont Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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