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Remote Information Counseling for Elders (RICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kimberly Hemmerlein, Indiana University
ClinicalTrials.gov Identifier:
NCT01203995
First received: September 1, 2010
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.


Condition Intervention
Obesity
 Behavioral: Nutrition information
Behavioral: Nutrition education and exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Remote Information Counseling for Elders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • BMI [ Time Frame: two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2-Minute Step Test [ Time Frame: two months ] [ Designated as safety issue: No ]
    Number of steps completed in two minutes

  • Chair stand test [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Experimental: brief nutrition education Behavioral: Nutrition information
Brief nutrition education with take home reference materials and portion size tools
Active Comparator: In Center training Behavioral: Nutrition education and exercise training
Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.
Experimental: Video Conference training Behavioral: Nutrition education and exercise training
Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 40 to 64 years.
  2. One or more CHC visits in the past 12 months.
  3. Body-mass index of ≥30 and <50.
  4. English speaking.
  5. Access to telephone.
  6. A permanent address.
  7. Willingness to be randomized.
  8. Willingness to have computer installed in home.

Exclusion Criteria:

  1. Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
  2. Current diagnosis of psychosis or bipolar disorder.
  3. Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
  4. Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
  5. Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
  6. Unwilling or unable to provide informed consent.
  7. Receiving disability insurance.
  8. Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
  9. Enrolled in a weight loss program or study or member of household enrolled in study.
  10. Residence outside of Marion County, Indiana.
  11. Residence relocation plans within 12 months.
  12. Planned or prior bariatric surgery.
  13. Substance abuse.
  14. History of treatment for eating disorder.

  15. Unstable weight with loss or gain of ≥ 5% in last 3 months.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203995

Locations
United States, Indiana
HITS
Indianapolis, Indiana, United States, 46205
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Daniel O Clark, PhD. Indiana University Center for Aging
  More Information

No publications provided

Responsible Party: Kimberly Hemmerlein, Research Coordinator, Indiana University
ClinicalTrials.gov Identifier: NCT01203995     History of Changes
Other Study ID Numbers: 0710-65B
Study First Received: September 1, 2010
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013