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Healthy Creations: Community Based Lifestyle Intervention Validation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Susan Raatz, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01262313
First received: December 15, 2010
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Overweight
Obesity
 Behavioral: Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Healthy Creations: Community Based Lifestyle Intervention Validation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Percentage weight change from baseline [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • functional fitness [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.

  • insulin sensitivity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Changes in insulin sensitivity will be examined using a fasting blood draw.

  • Plasma Lipids [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Plasma lipids will be examined using fasting blood draws


Estimated Enrollment: 46
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Group
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
Participants in the intervention group will attend an 8-week group intervention discussing "Healthy Creations" lifestyle changes.
Experimental: lifestyle counseling intervention
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
Participants in the intervention group will attend an 8-week group intervention discussing "Healthy Creations" lifestyle changes.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262313

Locations
United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Susan K Raatz, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Additional Information:
Click here for more information about this Healthy Creations study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Susan Raatz, PhD, RD, Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01262313     History of Changes
Other Study ID Numbers: GFHNRC019
Study First Received: December 15, 2010
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013