Remote Information Counseling for Elders

NCT ID: NCT01203995

Last Updated: 2013-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

brief nutrition education

Group Type EXPERIMENTAL

Nutrition information

Intervention Type BEHAVIORAL

Brief nutrition education with take home reference materials and portion size tools

In Center training

Group Type ACTIVE_COMPARATOR

Nutrition education and exercise training

Intervention Type BEHAVIORAL

Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.

Video Conference training

Group Type EXPERIMENTAL

Nutrition education and exercise training

Intervention Type BEHAVIORAL

Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.

Interventions

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Nutrition information

Brief nutrition education with take home reference materials and portion size tools

Intervention Type BEHAVIORAL

Nutrition education and exercise training

Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Kimberly Hemmerlein

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel O Clark, PhD.

Role: PRINCIPAL_INVESTIGATOR

Indiana University Center for Aging

Locations

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HITS

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0710-65B

Identifier Type: -

Identifier Source: org_study_id

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