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A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Primary Purpose

Retirement, Weight Gain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Behavior change on physical activity and diet
Sponsored by
Wageningen University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retirement focused on measuring Prevention, Retirement, Physical activity, Diet, Weight gain, Body composition

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Apparently healthy and recently retired Exclusion Criteria: Using drugs that might influence body composition, digestion or physical activities

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

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

    Full Information

    First Posted
    July 15, 2005
    Last Updated
    April 20, 2010
    Sponsor
    Wageningen University
    Collaborators
    Netherlands Heart Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00122213
    Brief Title
    A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
    Official Title
    An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wageningen University
    Collaborators
    Netherlands Heart Foundation

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retirement, Weight Gain
    Keywords
    Prevention, Retirement, Physical activity, Diet, Weight gain, Body composition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavior change on physical activity and diet
    Primary Outcome Measure Information:
    Title
    Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure)
    Title
    Energy intake (Food Frequency Questionnaire)
    Title
    Physical activity level (Physical Activity Scale for the Elderly)
    Secondary Outcome Measure Information:
    Title
    Psychosocial factors (attitude, social influence, self-efficacy etc.)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Apparently healthy and recently retired Exclusion Criteria: Using drugs that might influence body composition, digestion or physical activities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Evert G Schouten, PhD
    Organizational Affiliation
    Wageningen University - Division of Human Nutrition
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20205704
    Citation
    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.
    Results Reference
    derived

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    A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

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