The Wildcat Wellness Coaching Trial

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:

• 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.

Study Overview

• Status: Unknown
• Conditions: Health Promotion and Obesity Prevention
• Intervention / Treatment: Behavioral: Wellness coaching

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education; Other Names: health 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; Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education; Other Names: health coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index Z-score	CDC age- and sex-referenced body mass index standardized score	change from baseline BMIz at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)	change from baseline at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of fruits and vegetables	Daily consumption of fruits and vegetables	change from baseline at 6 months
Physical activity	Weekly step count, minutes per day of moderate-to-vigorous physical activity, minutes per day of sedentary behavior	change from baseline at 6 months
body fat percentage	DEXA-assessed body fat percentage	change from baseline at 6 months
Waist circumference	Gulick tape measured horizontal distance around waist during exhale at midpoint of rib and iliac crest	change from baseline at 6 months

Collaborators and Investigators

• Sponsor: Kansas State University
• Investigators: Principal Investigator: Richard R. Rosenkranz, Rosenkranz, Kansas State University

Publications and helpful links

General 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.

Helpful Links

• Published protocol paper

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2012
• Primary Completion (Anticipated): September 20, 2017
• Study Completion (Anticipated): October 13, 2017

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; quality of life; nutrition; Body composition; Childhood obesity; health promotion; Lifestyle intervention; home-based; obesity prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: KSU-CHE-SRO-WWCT

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