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The Wildcat Wellness Coaching Trial

Primary Purpose

Health Promotion and Obesity Prevention

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness coaching
Sponsored by
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Promotion and Obesity Prevention focused on measuring health promotion, obesity prevention, Childhood obesity, home-based, Lifestyle intervention, Body composition, quality of life, physical activity, nutrition

Eligibility Criteria

8 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Physical Activity & Nutrition Clinical Research Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthful eating phys activity coaching

Health education coaching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life
Quality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)

Full Information

First Posted
April 29, 2013
Last Updated
February 22, 2017
Sponsor
Kansas State University
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1. Study Identification

Unique Protocol Identification Number
NCT01845480
Brief Title
The Wildcat Wellness Coaching Trial
Official Title
The Wildcat Wellness Coaching Trial: Home-based Obesity Prevention and Health Promotion in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2012 (Actual)
Primary Completion Date
September 20, 2017 (Anticipated)
Study Completion Date
October 13, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kansas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Promotion and Obesity Prevention
Keywords
health promotion, obesity prevention, Childhood obesity, home-based, Lifestyle intervention, Body composition, quality of life, physical activity, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthful eating phys activity coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Health education coaching
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wellness coaching
Other Intervention Name(s)
health coaching
Intervention Description
Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education
Primary Outcome Measure Information:
Title
body mass index Z-score
Description
CDC age- and sex-referenced body mass index standardized score
Time Frame
change from baseline BMIz at 6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life (PedsQL scales of physical functioning, social functioning, school functioning, emotional functioning)
Time Frame
change from baseline at 6 months
Other Pre-specified Outcome Measures:
Title
Consumption of fruits and vegetables
Description
Daily consumption of fruits and vegetables
Time Frame
change from baseline at 6 months
Title
Physical activity
Description
Weekly step count, minutes per day of moderate-to-vigorous physical activity, minutes per day of sedentary behavior
Time Frame
change from baseline at 6 months
Title
body fat percentage
Description
DEXA-assessed body fat percentage
Time Frame
change from baseline at 6 months
Title
Waist circumference
Description
Gulick tape measured horizontal distance around waist during exhale at midpoint of rib and iliac crest
Time Frame
change from baseline at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard R. Rosenkranz, Rosenkranz
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Activity & Nutrition Clinical Research Consortium
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27965845
Citation
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.
Results Reference
derived
Links:
URL
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0066-y
Description
Published protocol paper

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The Wildcat Wellness Coaching Trial

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