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The Wildcat Wellness Coaching Trial

The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01845480
Enrollment
66
Registered
2013-05-03
Start date
2012-08-20
Completion date
2017-10-13
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Promotion and Obesity Prevention

Keywords

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

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.

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.

Interventions

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

Sponsors

Kansas State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 13 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
body mass index Z-scorechange from baseline BMIz at 6 monthsCDC age- and sex-referenced body mass index standardized score

Secondary

MeasureTime frameDescription
Quality of lifechange from baseline at 6 monthsQuality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)

Other

MeasureTime frameDescription
Consumption of fruits and vegetableschange from baseline at 6 monthsDaily consumption of fruits and vegetables
Physical activitychange from baseline at 6 monthsWeekly step count, minutes per day of moderate-to-vigorous physical activity, minutes per day of sedentary behavior
body fat percentagechange from baseline at 6 monthsDEXA-assessed body fat percentage
Waist circumferencechange from baseline at 6 monthsGulick tape measured horizontal distance around waist during exhale at midpoint of rib and iliac crest

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026