NCT01203995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

2.1 years

First QC Date

September 1, 2010

Last Update Submit

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 INTERVENTION

brief nutrition education

EXPERIMENTAL
Behavioral: Nutrition information

In Center training

ACTIVE COMPARATOR
Behavioral: Nutrition education and exercise training

Video Conference training

EXPERIMENTAL
Behavioral: Nutrition education and exercise training

Interventions

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

brief nutrition education

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

In Center trainingVideo Conference training

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition AssessmentExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Daniel O Clark, PhD.

    Indiana University Center for Aging

    PRINCIPAL INVESTIGATOR

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

Locations