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Healthy Creations: Community Based Lifestyle Intervention Validation

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control Group

lifestyle counseling intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

functional fitness
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
Changes in insulin sensitivity will be examined using a fasting blood draw.
Plasma Lipids
Plasma lipids will be examined using fasting blood draws

Full Information

First Posted
December 15, 2010
Last Updated
August 1, 2018
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01262313
Brief Title
Healthy Creations: Community Based Lifestyle Intervention Validation
Official Title
Healthy Creations: Community Based Lifestyle Intervention Validation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
lifestyle counseling intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
Participants in the intervention group will attend an 8-week group intervention discussing "Healthy Creations" lifestyle changes.
Primary Outcome Measure Information:
Title
Percentage weight change from baseline
Description
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.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
functional fitness
Description
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.
Time Frame
20 weeks
Title
insulin sensitivity
Description
Changes in insulin sensitivity will be examined using a fasting blood draw.
Time Frame
20 weeks
Title
Plasma Lipids
Description
Plasma lipids will be examined using fasting blood draws
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Raatz, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20876408
Citation
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.
Results Reference
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PubMed Identifier
18155995
Citation
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.
Results Reference
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PubMed Identifier
19171813
Citation
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.
Results Reference
background
PubMed Identifier
19153582
Citation
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.
Results Reference
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Healthy Creations: Community Based Lifestyle Intervention Validation

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