Healthy Creations: Community Based Lifestyle Intervention Validation

Study Overview
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Brief Summary
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There remain important barriers to the translation of the programs like the Diabetes Prevention Program to public health. There is a lack of established lifestyle intervention programs as they are resource and time intensive, exceeding both the resources and the training of most primary care providers. A solution may be the implementation of lifestyle intervention programs in the community setting that are unrelated to primary medical care. A community based program at a public facility may extend the reach of lifestyle intervention to those unable to obtain these services from an established medical facility. Community lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a promising strategy for weight management and the reduction of risk for metabolic disease. In this validation study we will assess pre and post intervention to identify whether measurable changes can be detected in body weight, body composition, markers of metabolic disease and quality of life after participation in the Healthy Creations, a community based lifestyle intervention program presented by Center Court Fitness Center of the Grand Forks Park District and Altru Health System.

Official Title
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Healthy Creations: Community Based Lifestyle Intervention Validation

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or Class I and II obese live in Grand Forks, ND area Exclusion Criteria: history of eating disorder pregnancy inability to understand English or give consent uncontrolled medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>The Control group will have an hour-long meeting of instruction by a registered dietitian on using the provided A Healthier You: Everyday Healthy Eating and Physical Activity for Life book, based on the Dietary Guidelines for Americans 2005. | Behavioral: Lifestyle Counseling<br>* Participants in the intervention group will attend an 8-week group intervention discussing Healthy Creations lifestyle changes.<br>|
| Experimental: lifestyle counseling intervention<br>This group will participate in the weekly Healthy Creations classes for 8 weeks presented by a Registered Dietitian and a certified fitness trainer. This is a community based lifestyle intervention program. | Behavioral: Lifestyle Counseling<br>* Participants in the intervention group will attend an 8-week group intervention discussing Healthy Creations lifestyle changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage weight change from baseline | Participants in the intervention group will attend an 8-week group intervention of Healthy Creations. Participants in the control group will participate in one class on diet and physical activity presented by a dietitian. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional fitness | Functional fitness will be measured by a 6-minute walk test (cardio-respiratory fitness). Leg strength, core strength, upper body strength, flexibility, and balance will be measured. | 20 weeks | 
| insulin sensitivity | Changes in insulin sensitivity will be examined using a fasting blood draw. | 20 weeks | 
| Plasma Lipids | Plasma lipids will be examined using fasting blood draws | 20 weeks |