NCT02027077

Brief Summary

Obesity is a major risk factor for disease and a public health problem. Recent information suggests that while it is possible for most overweight adults to lose a substantial amount of weight, maintaining the weight loss for any extended time (2 to 3 years) is very difficult. This is because trying to maintain big changes in exercise and/or eating behaviour is very difficult in today's environment that makes sustain big changes in behaviour (Example: eat allot less or exercise allot more) very hard. In fact at this time health professionals are unsure of how best to help overweight adults maintain big behavioral changes for long periods of time. In response, we propose that making smaller changes in eating and exercise habits every day may be possible in today's environment and if so, small weight changes may be possible to maintain for long periods of time. This study is designed to assess whether making small changes in eating and exercise behavior will be associated with sustained weight loss over three (3) years. The results of the study may have important implications for development of public health messages and clinical guidelines for prevention and treatment of obesity through small changes in both exercise and eating habits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable obesity

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

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

January 18, 2019

Status Verified

April 1, 2017

Enrollment Period

4.3 years

First QC Date

January 2, 2014

Last Update Submit

January 17, 2019

Conditions

ObesityPrevention of Weight Gain

Keywords

physical activitydietsmall changebehavior change

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    2 years

Secondary Outcomes (3)

  • Waist Circumference

    2 years

  • Physical Activity

    2 years

  • Total and regional body composition measures

    2-years

Other Outcomes (1)

  • Cardiometabolic risk factors

    2 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group

Behavioral: Control group

Lifestyle counseling

ACTIVE COMPARATOR

Behavioral intervention group

Behavioral: Lifestyle counselling

Interventions

Control groupBEHAVIORAL

No prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention

Control group
Lifestyle counsellingBEHAVIORAL

Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.

Lifestyle counseling

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 25 and 65 years of age.
  • Overweight or Class I or Class II BMI.
  • Walk without assistance.
  • Commit to a schedule of assessment visits

You may not qualify if:

  • Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia.
  • Enrolled within past year in a formal weight loss program
  • Reported losing greater than 5% of current body weight in the previous 6 months,
  • Smoking
  • Plans to move from the area,
  • Participating in another research study.
  • Clinically judged to be unsuitable for participation or adherence as determined by the participants physician
  • Inability or unwillingness to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Helath Studies

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • Ross R, Latimer-Cheung AE, Day AG, Brennan AM, Hill JO. A small change approach to prevent long-term weight gain in adults with overweight and obesity: a randomized controlled trial. CMAJ. 2022 Mar 7;194(9):E324-E331. doi: 10.1503/cmaj.211041.

    PMID: 35256388DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Robert Ross, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

February 1, 2014

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

January 18, 2019

Record last verified: 2017-04

Locations

CA(1)