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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group Intervention
Cognitive behavioral experiential group therapy for health behavior change
Behavioral: Cognitive 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.
Other Names:
  • Kickstart Health

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Beaumont Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wayne State University
Blue Cross Blue Shield of Michigan Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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