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Healthy Creations: Community Based Lifestyle Intervention Validation

Healthy Creations: Community Based Lifestyle Intervention Validation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01262313
Enrollment
46
Registered
2010-12-17
Start date
2010-12-31
Completion date
2013-09-30
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

BEHAVIORALLifestyle Counseling

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

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage weight change from baseline20 weeksParticipants 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

MeasureTime frameDescription
functional fitness20 weeksFunctional 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 sensitivity20 weeksChanges in insulin sensitivity will be examined using a fasting blood draw.
Plasma Lipids20 weeksPlasma lipids will be examined using fasting blood draws

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026