Health BehaviorNCT03308162
The Kickstart Health Program
A study testing Cognitive behavioral experiential group therapy in people with Health Behavior, run by Corewell Health East at 1 site in United States.
Trial summary
This study is testing the acceptability and feasibility of an active, experiential group therapy for health behavior change within a medical setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Cognitive behavioral experiential group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Family Medicine
Sterling Heights, Michigan, 48314
About this study
Official title: 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.
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.
- Conditions
- Health Behavior
- Being tested
- Cognitive behavioral experiential group therapy
- Keywords
- Integrated Behavioral Health Care
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral experiential group therapyBehavioural
Also called Kickstart Health
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention | Experimental | Cognitive behavioral experiential group therapy for health behavior change Receives: Behavioral: Cognitive behavioral experiential group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility
Survey measure of acceptability and feasibility of the novel study in a health care setting
Measured: 5 weeks
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
Measured: 13 weeks
Secondary outcomes (28)
Personal Medical History Questionnaire
Measure of relevant medical history
Measured: Baseline
Health Specific Self Efficacy Scales
Measure of one's belief that one can engage in health behavior and it is important
Measured: Baseline
Change in health specific self efficacy from baseline
Measure of one's belief that one can engage in health behavior and it is important
Measured: 5-weeks
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
Measured: 13-weeks
Exercise Beliefs and Benefits Scale (EBBS)
Measure of one's belief that one can engage in exercise and it is important
Measured: Baseline, 5-, and 13-weeks
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
Measured: 5-weeks
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
Measured: 13-weeks
Short Form 8 (SF-8)
Measure of subjective health
Measured: Baseline, 5-, and 13-weeks
Change in SF-8 from baseline
Measure of subjective health
Measured: 5-weeks
Change in SF-8 from 5 weeks
Measure of subjective health
Measured: 13-weeks
International Physical Activity Questionnaire (IPAQ)
Measure of weekly physical activity
Measured: Baseline, 5-, and 13-weeks
Change in International Physical Activity Questionnaire (IPAQ) from baseline
Measure of weekly physical activity
Measured: 5-weeks
Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks
Measure of weekly physical activity
Measured: 13-weeks
Simple Food Frequency Questionnaire (S-FFQ)
Measure of food consumption across different food groups
Measured: Baseline
Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline
Measure of food consumption across different food groups
Measured: 5-weeks
Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks
Measure of food consumption across different food groups
Measured: 13-weeks
Satisfaction with Life Scale (SWL)
Measure of overall well being
Measured: Baseline, 5-, and 13-weeks
Change in Satisfaction with Life Scale (SWL) from baseline
Measure of overall well being
Measured: 5-weeks
Change in Satisfaction with Life Scale (SWL) from 5-weeks
Measure of overall well being
Measured: 13-weeks
The Group Attitude Scale
Measure of group cohesion
Measured: 5-weeks
Change in The Group Attitude Scale from 5-weeks
Measure of group cohesion
Measured: 13-weeks
Height
Measure of self reported high
Measured: Baseline
Weight
Measure of self reported weight
Measured: Baseline
Change in weight from baseline
Measure of self reported weight
Measured: 5-weeks
Change in weight from 5-weeks
Measure of self reported weight
Measured: 13-weeks
Average daily steps
Measure of self reported average daily steps
Measured: Baseline
Change in average daily steps from baseline
Measure of self reported average daily steps
Measured: 5-weeks
Change in average daily steps from 5-weeks
Measure of self reported average daily steps
Measured: 13-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start10 Oct 2017
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subjects repeated measures
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University, Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Lackman-Zeman, Lori A, PhD, Corewell Health East
- Investigators
- Lori Lackman-Zeman, PhD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308162
- Sponsor's protocol ID
- 2017-270
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Multicomponent Group Intervention to Initiate Health Behavior Change: The Kickstart Health Program
- ClinicalTrials.gov ID
- NCT03308162
- Acronym / sponsor ID
- 2017-270
- Conditions
- Health Behavior
- Keywords
- Integrated Behavioral Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Wayne State University, Blue Cross Blue Shield of Michigan Foundation
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subjects repeated measures
| Arm | Type | Receives |
|---|---|---|
| Group Intervention | Experimental | Behavioral: Cognitive behavioral experiential group therapyCognitive behavioral experiential group therapy for health behavior change |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral experiential group therapyAlso: Kickstart HealthThe 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. | Behavioural | Group Intervention |
Primary outcome
Acceptability and feasibility
Time frame: 5 weeks
Survey measure of acceptability and feasibility of the novel study in a health care setting
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
28 secondary outcomes
Personal Medical History Questionnaire
Time frame: Baseline
Health Specific Self Efficacy Scales
Time frame: Baseline
Change in health specific self efficacy from baseline
Time frame: 5-weeks
Change in health specific self efficacy from 5-weeks
Time frame: 13-weeks
Exercise Beliefs and Benefits Scale (EBBS)
Time frame: Baseline, 5-, and 13-weeks
Change in exercise Beliefs and Benefits Scale (EBBS) from baseline
Time frame: 5-weeks
Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks
Time frame: 13-weeks
Short Form 8 (SF-8)
Time frame: Baseline, 5-, and 13-weeks
Change in SF-8 from baseline
Time frame: 5-weeks
Change in SF-8 from 5 weeks
Time frame: 13-weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 5-, and 13-weeks
Change in International Physical Activity Questionnaire (IPAQ) from baseline
Time frame: 5-weeks
Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks
Time frame: 13-weeks
Simple Food Frequency Questionnaire (S-FFQ)
Time frame: Baseline
Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline
Time frame: 5-weeks
Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks
Time frame: 13-weeks
Satisfaction with Life Scale (SWL)
Time frame: Baseline, 5-, and 13-weeks
Change in Satisfaction with Life Scale (SWL) from baseline
Time frame: 5-weeks
Change in Satisfaction with Life Scale (SWL) from 5-weeks
Time frame: 13-weeks
The Group Attitude Scale
Time frame: 5-weeks
Change in The Group Attitude Scale from 5-weeks
Time frame: 13-weeks
Height
Time frame: Baseline
Weight
Time frame: Baseline
Change in weight from baseline
Time frame: 5-weeks
Change in weight from 5-weeks
Time frame: 13-weeks
Average daily steps
Time frame: Baseline
Change in average daily steps from baseline
Time frame: 5-weeks
Change in average daily steps from 5-weeks
Time frame: 13-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Health Behavior
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Lackman-Zeman, PhD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral experiential group therapy in people with Health Behavior, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and feasibility (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.