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Clinical Trials/NCT01203995
NCT01203995CompletedNot Applicable

Remote Information Counseling for Elders

Indiana University2 sites in 1 country64 target enrollmentStarted: August 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
BMI
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Aged 40 to 64 years.
  • •One or more CHC visits in the past 12 months.
  • •Body-mass index of ≥30 and <
  • •English speaking.
  • •Access to telephone.
  • •A permanent address.
  • •Willingness to be randomized.
  • •Willingness to have computer installed in home.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

BMI

Time Frame: two months

Secondary Outcomes

  • 2-Minute Step Test(two months)
  • Chair stand test(2 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kimberly Hemmerlein

Research Coordinator

Indiana University

Study Sites (2)

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Remote Information Counseling for Elders | Clinical Trial