Healthy Creations: Community Based Lifestyle Intervention Validation

NCT01262313 | Completed

• 1 other identifier: GFHNRC019
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• functional fitness

  20 weeks

• insulin sensitivity

  20 weeks

• Plasma Lipids

  20 weeks

Study Arms (2)

Control Group

SHAM COMPARATOR

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

lifestyle counseling intervention

EXPERIMENTAL

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

Interventions

Lifestyle Counseling BEHAVIORAL

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

Control Group; lifestyle counseling intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight or Class I and II obese
• live in Grand Forks, ND area

You may not qualify if:

• history of eating disorder
• pregnancy
• inability to understand English or give consent
• uncontrolled medical condition

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

Location

Related Publications (4)

• 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.

  PMID: 20876408 BACKGROUND

• 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.

  PMID: 18155995 BACKGROUND

• 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.

  PMID: 19171813 BACKGROUND

• 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.

  PMID: 19153582 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan K Raatz, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

US (1)