CClinicalTrials.gg
Status unknownNCT01845480Updated Feb 24, 2017

The Wildcat Wellness Coaching Trial

An interventional study of Wellness coaching in Health Promotion and Obesity Prevention, sponsored by Kansas State University. Status unknown at 1 site in United States. Open to female participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Kansas State University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2012, registered Apr 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
Female
01

Study 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 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.

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.

02

Conditions studied

  • Health Promotion and Obesity Prevention

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Keywords

  • health promotion
  • obesity prevention
  • Childhood obesity
  • home-based
  • Lifestyle intervention
  • Body composition
  • quality of life
  • physical activity
  • nutrition
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 66 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Kansas State University is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being a female aged 8 to 13 years with consenting parent or guardian
  • Family willing to participate in home-based behavioral intervention

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Healthful eating phys activity coaching

    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.

    Behavioral: Wellness coaching

  • Active comparator
    Health education coaching

    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.

    Behavioral: Wellness coaching

Interventions

  • BehavioralWellness coaching

    Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education

    Also known as: health coaching

06

What researchers measure

Primary outcomes

  1. body mass index Z-score

    CDC age- and sex-referenced body mass index standardized score

    Time frame: 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)

    Time frame: change from baseline at 6 months

Other outcomes

  1. Consumption of fruits and vegetables

    Daily consumption of fruits and vegetables

    Time frame: change from baseline at 6 months

  2. Physical activity

    Weekly step count, minutes per day of moderate-to-vigorous physical activity, minutes per day of sedentary behavior

    Time frame: change from baseline at 6 months

  3. body fat percentage

    DEXA-assessed body fat percentage

    Time frame: change from baseline at 6 months

  4. Waist circumference

    Gulick tape measured horizontal distance around waist during exhale at midpoint of rib and iliac crest

    Time frame: change from baseline at 6 months

07

Study locations

1 site
  • Physical Activity & Nutrition Clinical Research Consortium
    Manhattan, Kansas 66506, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01845480
Lead sponsor
Kansas State University
Responsible party
Richard R. Rosenkranz (Associate Professor, Kansas State University) — Principal investigator
First posted
May 3, 2013
Start date
Aug 20, 2012
Primary completion
Sep 20, 2017 (estimated)
Completion
Oct 13, 2017 (estimated)
Last update
Feb 24, 2017

Study contacts

Richard R. Rosenkranz, Rosenkranz
principal investigator · Kansas State University

Oversight

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

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