NCT00122213

Brief Summary

Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat. To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours. After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

2.4 years

First QC Date

July 15, 2005

Last Update Submit

April 20, 2010

Conditions

RetirementWeight Gain

Keywords

PreventionRetirementPhysical activityDietWeight gainBody composition

Outcome Measures

Primary Outcomes (3)

  • Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure)

  • Energy intake (Food Frequency Questionnaire)

  • Physical activity level (Physical Activity Scale for the Elderly)

Secondary Outcomes (1)

  • Psychosocial factors (attitude, social influence, self-efficacy etc.)

Interventions

Behavior change on physical activity and dietBEHAVIORAL

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy and recently retired

You may not qualify if:

  • Using drugs that might influence body composition, digestion or physical activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Werkman A, Hulshof PJ, Stafleu A, Kremers SP, Kok FJ, Schouten EG, Schuit AJ. Effect of an individually tailored one-year energy balance programme on body weight, body composition and lifestyle in recent retirees: a cluster randomised controlled trial. BMC Public Health. 2010 Mar 5;10:110. doi: 10.1186/1471-2458-10-110.

    PMID: 20205704DERIVED

MeSH Terms

Conditions

Weight GainMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Evert G Schouten, PhD

    Wageningen University - Division of Human Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

September 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

April 21, 2010

Record last verified: 2010-04