Health Promotion and Obesity PreventionNCT01845480
The Wildcat Wellness Coaching Trial
A study testing Wellness coaching in people with Health Promotion and Obesity Prevention, run by Kansas State University at 1 site in United States.
Trial summary
Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching… Read more about this study
- Who is it for?
- Ages 8 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Promotion and Obesity Prevention
- What is being tested?
- Wellness coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2012to 13 Oct 2017
- 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 8 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a female aged 8 to 13 years with consenting parent or guardian
- Family willing to participate in home-based behavioral intervention
Who cannot join
- Having developmental delay or psychiatric problems.
- Having any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity.
- Not living within 40 miles of Kansas State University campus in Manhattan, KS.
- Taking weight-altering medications, or participating in any other weight control program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity & Nutrition Clinical Research Consortium
Manhattan, Kansas, 66506
About this study
Official title: The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents
Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child.
Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures. Biomedical measurements to be obtained include:
Read more
- body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)
- blood pressure (automated sphygmomanometer),
- pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity, forced expiratory flow at 25-75% of vital capacity),
- unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,
- and physical activity levels (7-day accelerometry).
Psychosocial measurements include:
- fruit and vegetable consumption (Child Dietary Questionnaire)
- self efficacy,
- enjoyment
- quality of life (Peds QL).
Inclusion criteria are:
- being female
- aged 8-13 years
- with parental consent,
- residing within a 40-minute drive
- being available for 12 home coaching visits and three lab assessments.
Exclusion criteria are
- having developmental delay or psychiatric problems,
- any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity,
- taking weight-altering medications
- participating in any other health behavior change program.
The objectives of this study are to determine
- whether both types of the home-based coaching interventions are feasible
- whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in preventing increases in body fat percentage, body mass index percentile, waist circumference, systolic and diastolic blood pressure, and sedentary behavior
- whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in facilitating increases in quality of life, moderate-to-vigorous physical activity, enjoyment of physical activity and fruit and vegetable consumption, and self-efficacy for physical activity and fruit and vegetable consumption.
We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.
Read the detailed description
Obesity is associated with increased chronic disease risk, and therefore poses a major public health problem (Lobstein et al., 2004). In 2011, the Centers for Disease Control and Prevention estimated that obesity affects about 12.5 million children and teens, or 17% of the US population. This is a marked increase from the ~5% rate of obesity found in this population in the late 1960s. Barlow (2007) points out that the complexity of obesity prevention lies less in the identification of target health behaviors, and much more in a process of influencing families to change behaviors when habits, culture, and environment promote less physical activity and more energy intake.
Obesity prevention interventions may not be effective or sustainable without impacting home environments (Rosenkranz \& Dzewaltowski, 2008). Conwell et al. (2010) suggest that home-based programs may offer significant advantages over center-based programs by offering better accessibility and convenience. Wellness coaching has shown promise for improving health behaviors related to chronic disease (Lawn \& Schoo, 2010), but no published study has used a wellness coaching childhood obesity prevention model in the home environment.
The primary aim of this trial is to determine whether the home-based wellness coaching delivery model is feasible as an obesity prevention intervention strategy in the community setting. The secondary objective is to determine the comparative effectiveness of the two wellness coaching interventions.
Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child. Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures.
We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.
- Conditions
- Health Promotion and Obesity Prevention
- Being tested
- Wellness coaching
- Keywords
- health promotion, obesity prevention, Childhood obesity, home-based, Lifestyle intervention, Body composition, quality of life, physical activity, nutrition
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness coachingBehavioural
Also called health coaching
Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education
| Study group | Role | What they receive |
|---|---|---|
| Healthful eating phys activity coaching | Experimental | The healthful eating and physical activity skills coaching intervention is designed to help children set goals and self-monitor healthful eating and physical activity; teach kitchen skills for fruit and vegetable snack preparation; teach children enjoyable physical activities to do at home (e.g., dancing); and provide modeling and social support for physical activity and healthful eating. Receives: Behavioral: Wellness coaching |
| Health education coaching | Active comparator | Health education coaching is designed to help children set goals and self-monitor behavior; educate children on a range of relevant health promotion behaviors (e.g., tooth brushing, not smoking, physical activity, etc.); and provide modeling and social support for practicing healthful behavior. Receives: Behavioral: Wellness coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index Z-score
CDC age- and sex-referenced body mass index standardized score
Measured: change from baseline BMIz at 6 months
Secondary outcomes (1)
Quality of life
Quality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)
Measured: change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start20 Aug 2012
- Primary completion20 Sep 2017 (estimated)
- Study completion13 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Promotion and Obesity PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard R. Rosenkranz, Kansas State University
- Investigators
- Richard R. Rosenkranz, Rosenkranz, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845480
- Sponsor's protocol ID
- KSU-CHE-SRO-WWCT
- Status last verified
- Feb 2017
- First submitted
- 29 Apr 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cull BJ, Rosenkranz SK, Dzewaltowski DA, Teeman CS, Knutson CK, Rosenkranz RR. Wildcat wellness coaching feasibility trial: protocol for home-based health behavior mentoring in girls. Pilot Feasibility Stud. 2016 Jun 1;2:26. doi: 10.1186/s40814-016-0066-y. eCollection 2016.
PubMed 27965845
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01845480
- Acronym / sponsor ID
- KSU-CHE-SRO-WWCT
- Conditions
- Health Promotion and Obesity Prevention
- Keywords
- health promotion, obesity prevention, Childhood obesity, home-based, Lifestyle intervention, Body composition, quality of life, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 20 Aug 2012 (actual)
- Primary completion
- 20 Sep 2017 (estimated)
- Study completion
- 13 Oct 2017 (estimated)
- First posted
- 3 May 2013 (estimated)
- 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.
Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child.
Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures. Biomedical measurements to be obtained include:
- body composition (DEXA, tetrapolar bioimpedance, body mass index, waist circumference)
- blood pressure (automated sphygmomanometer),
- pulmonary function tests (forced expiratory flow in 1-sec, forced vital capacity, forced expiratory flow at 25-75% of vital capacity),
- unstimulated whole (mixed) saliva passive drool to detect markers of inflammation,
- and physical activity levels (7-day accelerometry).
Psychosocial measurements include:
- fruit and vegetable consumption (Child Dietary Questionnaire)
- self efficacy,
- enjoyment
- quality of life (Peds QL).
Inclusion criteria are:
- being female
- aged 8-13 years
- with parental consent,
- residing within a 40-minute drive
- being available for 12 home coaching visits and three lab assessments.
Exclusion criteria are
- having developmental delay or psychiatric problems,
- any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity,
- taking weight-altering medications
- participating in any other health behavior change program.
The objectives of this study are to determine
- whether both types of the home-based coaching interventions are feasible
- whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in preventing increases in body fat percentage, body mass index percentile, waist circumference, systolic and diastolic blood pressure, and sedentary behavior
- whether the healthful eating and physical activity skills coaching intervention is more efficacious, relative to the general health education coaching group, in facilitating increases in quality of life, moderate-to-vigorous physical activity, enjoyment of physical activity and fruit and vegetable consumption, and self-efficacy for physical activity and fruit and vegetable consumption.
We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.
Detailed description
Obesity is associated with increased chronic disease risk, and therefore poses a major public health problem (Lobstein et al., 2004). In 2011, the Centers for Disease Control and Prevention estimated that obesity affects about 12.5 million children and teens, or 17% of the US population. This is a marked increase from the ~5% rate of obesity found in this population in the late 1960s. Barlow (2007) points out that the complexity of obesity prevention lies less in the identification of target health behaviors, and much more in a process of influencing families to change behaviors when habits, culture, and environment promote less physical activity and more energy intake.
Obesity prevention interventions may not be effective or sustainable without impacting home environments (Rosenkranz \& Dzewaltowski, 2008). Conwell et al. (2010) suggest that home-based programs may offer significant advantages over center-based programs by offering better accessibility and convenience. Wellness coaching has shown promise for improving health behaviors related to chronic disease (Lawn \& Schoo, 2010), but no published study has used a wellness coaching childhood obesity prevention model in the home environment.
The primary aim of this trial is to determine whether the home-based wellness coaching delivery model is feasible as an obesity prevention intervention strategy in the community setting. The secondary objective is to determine the comparative effectiveness of the two wellness coaching interventions.
Female children (aged 8-13 years) will be recruited through posted flyers, newspaper ads, and word of mouth in the Manhattan, KS area. After laboratory assessment, recruited participants will be randomly assigned to either healthful eating and physical activity skills coaching or general health education coaching intervention conditions. For both conditions, research assistants will serve as wellness coaches and deliver 12 intervention sessions in the home of each participating child. Assessments will be completed at baseline, intervention end (3 months), and follow-up (6 months), comprising biomedical and psychosocial measures.
We hypothesize that the research project will be successful in recruiting and retaining participating families, training research assistants to deliver the intervention components, and that both of the coaching conditions will be well received and appreciated by participating families. We hypothesize that the healthful eating and physical activity skills coaching intervention will be more effective than the support coaching condition in preventing increases in blood pressure, airway dysfunction and adiposity. We expect that both intervention conditions will show improvements to pediatric quality of life measures, but that the healthful eating and physical activity skills coaching intervention will be more effective than general health education coaching condition in increasing physical activity, physical activity enjoyment and self efficacy, fruit and vegetable consumption, and fruit and vegetable enjoyment and self-efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthful eating phys activity coaching | Experimental | Behavioral: Wellness coachingThe healthful eating and physical activity skills coaching intervention is designed to help children set goals and self-monitor healthful eating and physical activity; teach kitchen skills for fruit and vegetable snack preparation; teach children enjoyable physical activities to do at home (e.g., dancing); and provide modeling and social support for physical activity and healthful eating. |
| Health education coaching | Active comparator | Behavioral: Wellness coachingHealth education coaching is designed to help children set goals and self-monitor behavior; educate children on a range of relevant health promotion behaviors (e.g., tooth brushing, not smoking, physical activity, etc.); and provide modeling and social support for practicing healthful behavior. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being a female aged 8 to 13 years with consenting parent or guardian
- Family willing to participate in home-based behavioral intervention
Key exclusion criteria (4 listed)
- Having developmental delay or psychiatric problems.
- Having any illness, injury, condition, or disease that would prevent participation in moderate-to-vigorous physical activity.
- Not living within 40 miles of Kansas State University campus in Manhattan, KS.
- Taking weight-altering medications, or participating in any other weight control program.
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 |
|---|---|---|
| Wellness coachingAlso: health coachingWellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education | Behavioural | Health education coaching, Healthful eating phys activity coaching |
Primary outcome
body mass index Z-score
Time frame: change from baseline BMIz at 6 months
CDC age- and sex-referenced body mass index standardized score
1 secondary outcome
Quality of life
Time frame: change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Derived from this study: PubMed 27965845Cull BJ, Rosenkranz SK, Dzewaltowski DA, Teeman CS, Knutson CK, Rosenkranz RR. Wildcat wellness coaching feasibility trial: protocol for home-based health behavior mentoring in girls. Pilot Feasibility Stud. 2016 Jun 1;2:26. doi: 10.1186/s40814-016-0066-y. eCollection 2016.
- Published protocol paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Richard R. Rosenkranz, Rosenkranz principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness coaching in people with Health Promotion and Obesity Prevention, run by Kansas State University 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 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2017. 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?
Results are not available in the source record.
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?
body mass index Z-score (time frame: change from baseline BMIz at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01845480, which also lists 1 linked publication.
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 24 Feb 2017; AzTrials last refreshed its copy on 29 Oct 2026.