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OpenTrials
Completed

NCT Number: NCT01262313

Healthy Creations: Community Based Lifestyle Intervention Validation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

Participants in the intervention group will attend an 8-week group intervention discussing "Healthy Creations" lifestyle changes.

Primary outcomes

  1. Percentage weight change from baseline

    Time frame: 20 weeks

    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 outcomes

  1. functional fitness

    Time frame: 20 weeks

    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.

  2. insulin sensitivity

    Time frame: 20 weeks

    Changes in insulin sensitivity will be examined using a fasting blood draw.

  3. Plasma Lipids

    Time frame: 20 weeks

    Plasma lipids will be examined using fasting blood draws

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2010
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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