NCT00334269

Brief Summary

The purpose of this study is to develop an effective intervention strategy to prevent \& reduce obesity among a high risk cohort of Aboriginal families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2006

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

First QC Date

June 6, 2006

Last Update Submit

September 27, 2009

Conditions

Keywords

obesityphysical activitydaily energy intakenutritionhealthy lifestyleAboriginalbody fatexerciseeducationfamilybody mass indexknowledgerandomized controlled trialcommunityinterventionSix Nations Indian Reservehouseholdhealth counselling

Outcome Measures

Primary Outcomes (1)

  • The primary outcomes of the pilot study include the change from baseline in daily energy intake (kcal per day), and the change in physical activity (minutes/week).

Secondary Outcomes (1)

  • Secondary outcomes include the changes (from baseline to end of study) in knowledge and attitudes toward healthy lifestyles, self/response efficacy, body fat, BMI, abdominal fat, blood pressure, glucose, and lipids.

Interventions

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible households are defined as those comprised of a male and female parent with at least one child \< 19 years old living in the same household
  • Individuals between 5 and 65 years of age (including grandparents) are included
  • Families must be living on Six Nations Indian Reserve, Ontario, Canada

You may not qualify if:

  • Are not willing to have the SHARE-AP ACTION Health Counsellor visit their home on a weekly basis,
  • Have a planned absence from the Reservation for \> 1 month during the intervention, and
  • if there is a planned break-up of the household in the next 1 year
  • Individual members will be excluded from the household unit if they have:
  • A serious medical illness which prevent them from making dietary and exercise changes (e.g.dialysis dependent),
  • Terminal cancer,
  • Suspected severe alcohol abuse, or
  • have suffered a recent MI or stroke in the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHARE-AP Office, Six Nations Health Services P.O. Box 5000

Ohsweken, Ontario, N0A 1M0, Canada

Location

Related Publications (2)

  • Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.

    PMID: 11071182BACKGROUND
  • Davis SM, Going SB, Helitzer DL, Teufel NI, Snyder P, Gittelsohn J, Metcalfe L, Arviso V, Evans M, Smyth M, Brice R, Altaha J. Pathways: a culturally appropriate obesity-prevention program for American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):796S-802S. doi: 10.1093/ajcn/69.4.796S.

    PMID: 10195605BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Sonia S Anand, MD, PhD

    Population Health Research Institute, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 7, 2006

Study Start

May 1, 2004

Study Completion

December 1, 2005

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations