Remote Information Counseling for Elders
RICE
1 other identifier
interventional
64
1 country
1
Brief Summary
The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 2, 2013
March 1, 2013
2.1 years
September 1, 2010
March 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
BMI
two months
Secondary Outcomes (2)
2-Minute Step Test
two months
Chair stand test
2 month
Study Arms (4)
Usual Care
NO INTERVENTIONbrief nutrition education
EXPERIMENTALIn Center training
ACTIVE COMPARATORVideo Conference training
EXPERIMENTALInterventions
Brief nutrition education with take home reference materials and portion size tools
Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.
Eligibility Criteria
You may qualify if:
- Aged 40 to 64 years.
- One or more CHC visits in the past 12 months.
- Body-mass index of ≥30 and \<50.
- English speaking.
- Access to telephone.
- A permanent address.
- Willingness to be randomized.
- Willingness to have computer installed in home.
You may not qualify if:
- 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).
- Current diagnosis of psychosis or bipolar disorder.
- Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
- Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
- Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
- Unwilling or unable to provide informed consent.
- Receiving disability insurance.
- Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
- Enrolled in a weight loss program or study or member of household enrolled in study.
- Residence outside of Marion County, Indiana.
- Residence relocation plans within 12 months.
- Planned or prior bariatric surgery.
- Substance abuse.
- History of treatment for eating disorder.
- Unstable weight with loss or gain of ≥ 5% in last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HITS
Indianapolis, Indiana, 46205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel O Clark, PhD.
Indiana University Center for Aging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 17, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
April 2, 2013
Record last verified: 2013-03