Remote Information Counseling for Elders (RICE)

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Nutrition information; Behavioral: Nutrition education and exercise training

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46205
      • HITS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Minute Step Test	Number of steps completed in two minutes	two months
Chair stand test		2 month

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Daniel O Clark, PhD., Indiana University Center for Aging

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 1, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 2, 2013
• Last Update Submitted That Met QC Criteria: March 29, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 0710-65B