Healthy Creations: Community Based Lifestyle Intervention Validation

NCT ID: NCT01262313

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type SHAM_COMPARATOR

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle Counseling

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan K Raatz, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

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USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

References

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Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.

Reference Type BACKGROUND
PMID: 20876408 (View on PubMed)

Raatz SK, Wimmer JK, Kwong CA, Sibley SD. Intensive diet instruction by registered dietitians improves weight-loss success. J Am Diet Assoc. 2008 Jan;108(1):110-3. doi: 10.1016/j.jada.2007.10.010.

Reference Type BACKGROUND
PMID: 18155995 (View on PubMed)

Williamson DA, Rejeski J, Lang W, Van Dorsten B, Fabricatore AN, Toledo K; Look AHEAD Research Group. Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetes. Arch Intern Med. 2009 Jan 26;169(2):163-71. doi: 10.1001/archinternmed.2008.544.

Reference Type BACKGROUND
PMID: 19171813 (View on PubMed)

Jakicic JM, Jaramillo SA, Balasubramanyam A, Bancroft B, Curtis JM, Mathews A, Pereira M, Regensteiner JG, Ribisl PM; Look AHEAD Study Group. Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD Study. Int J Obes (Lond). 2009 Mar;33(3):305-16. doi: 10.1038/ijo.2008.280. Epub 2009 Jan 20.

Reference Type BACKGROUND
PMID: 19153582 (View on PubMed)

Other Identifiers

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GFHNRC019

Identifier Type: -

Identifier Source: org_study_id

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