The Wildcat Wellness Coaching Trial

NCT01845480 | Unknown

• 1 other identifier: KSU-CHE-SRO-WWCT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Promotion and Obesity Prevention

Keywords

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

Outcome Measures

Primary Outcomes (1)

• body mass index Z-score

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

  change from baseline BMIz at 6 months

Secondary Outcomes (1)

• Quality of life

  change from baseline at 6 months

Other Outcomes (4)

• Consumption of fruits and vegetables

  change from baseline at 6 months

• Physical activity

  change from baseline at 6 months

• body fat percentage

  change from baseline at 6 months

Study Arms (2)

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.

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.

Behavioral: Wellness coaching

Interventions

Wellness coaching BEHAVIORAL

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

Also known as: health coaching

Health education coaching; Healthful eating phys activity coaching

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kansas State University: lead

Study Sites (1)

Physical Activity & Nutrition Clinical Research Consortium

Manhattan, Kansas, 66506, United States

Location

Related Publications (1)

• 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.

  PMID: 27965845 DERIVED

Related Links

• Published protocol paper

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Richard R. Rosenkranz, Rosenkranz

  Kansas State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: August 20, 2012
• Primary Completion: September 20, 2017
• Study Completion: October 13, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)