The Wildcat Wellness Coaching Trial

Status unconfirmed · Not applicable

Conditions studied: Health Promotion and Obesity Prevention

In brief

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.

Key facts

Study ID

NCT01845480

Run by

Kansas State University

People needed

66

Starts

2012-08-20

Expected to finish

2017-10-13

Last updated by the study team

2017-02-24

Who can join

Age: 8 and older, up to 13. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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