Healthy Creations: Community Based Lifestyle Intervention Validation

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Lifestyle Counseling

• Registration Number: NCT01262313
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle counseling intervention	Lifestyle Counseling	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.
Control Group	Lifestyle Counseling	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.

Primary Outcome Measures

Name	Time	Method
Percentage weight change from baseline	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 Outcome Measures

Name	Time	Method
functional fitness	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.
insulin sensitivity	20 weeks	Changes in insulin sensitivity will be examined using a fasting blood draw.
Plasma Lipids	20 weeks	Plasma lipids will be examined using fasting blood draws

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States