The Wildcat Wellness Coaching Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Kansas State University
Sponsor:
Information provided by (Responsible Party):
Richard R. Rosenkranz, Kansas State University
ClinicalTrials.gov Identifier:
NCT01845480
First received: April 29, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Health Promotion and Obesity Prevention
Behavioral: Wellness coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Kansas State University:

Primary Outcome Measures:
  • body mass index Z-score [ Time Frame: change from baseline BMIz at 6 months ] [ Designated as safety issue: No ]
    CDC age- and sex-referenced body mass index standardized score


Secondary Outcome Measures:
  • Quality of life [ Time Frame: change from baseline at 6 months ] [ Designated as safety issue: No ]
    Quality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)


Other Outcome Measures:
  • Consumption of fruits and vegetables [ Time Frame: change from baseline at 6 months ] [ Designated as safety issue: No ]
    Daily consumption of fruits and vegetables

  • Physical activity [ Time Frame: change from baseline at 6 months ] [ Designated as safety issue: No ]
    Weekly step count, minutes per day of moderate-to-vigorous physical activity, minutes per day of sedentary behavior

  • body fat percentage [ Time Frame: change from baseline at 6 months ] [ Designated as safety issue: No ]
    DEXA-assessed body fat percentage

  • Waist circumference [ Time Frame: change from baseline at 6 months ] [ Designated as safety issue: No ]
    Gulick tape measured horizontal distance around waist during exhale at midpoint of rib and iliac crest


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthful eating and physical activity wellness 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 Name: health coaching
Active Comparator: Health education coaching
The health education coaching intervention 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 Name: health 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.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845480

Contacts
Contact: Richard R. Rosenkranz, PhD 7855320152 ricardo@ksu.edu

Locations
United States, Kansas
Physical Activity & Nutrition Clinical Research Consortium Recruiting
Manhattan, Kansas, United States, 66506
Contact: Richard R Rosenkranz, PhD    785-532-0152    ricardo@ksu.edu   
Contact: Sara K Rosenkranz, PhD       sararose@ksu.edu   
Sub-Investigator: David A Dzewaltowski, PhD         
Sub-Investigator: Sara K Rosenkranz, PhD         
Sponsors and Collaborators
Kansas State University
Investigators
Principal Investigator: Richard R. Rosenkranz, Rosenkranz Kansas State University
  More Information

Additional Information:
No publications provided

Responsible Party: Richard R. Rosenkranz, Assistant Professor, Kansas State University
ClinicalTrials.gov Identifier: NCT01845480     History of Changes
Other Study ID Numbers: KSU-CHE-SRO-WWCT
Study First Received: April 29, 2013
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kansas State University:
health promotion
obesity prevention
Childhood obesity
home-based
Lifestyle intervention
Body composition
quality of life
physical activity
nutrition

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014