RetirementPhase 2NCT00122213
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
A Phase 2 study testing Behavior change on physical activity and diet in people with Retirement and Weight Gain, run by Wageningen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Retirement, Weight Gain
- What is being tested?
- Behavior change on physical activity and diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy and recently retired
Who cannot join
- Using drugs that might influence body composition, digestion or physical activities
About this study
Official title: An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
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.
- Conditions
- Retirement, Weight Gain
- Being tested
- Behavior change on physical activity and diet
- Keywords
- Prevention, Retirement, Physical activity, Diet, Weight gain, Body composition
- Medical subject headings
- Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior change on physical activity and dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startSep 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetirementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Investigators
- Evert G Schouten, PhD, Study chair, Wageningen University - Division of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122213
- Sponsor's protocol ID
- 2000T205
- Status last verified
- Apr 2010
- First submitted
- 15 Jul 2005
- Last updated
- 21 Apr 2010
- Results posted
- No
Publications
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.
PubMed 20205704
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
- ClinicalTrials.gov ID
- NCT00122213
- Acronym / sponsor ID
- 2000T205
- Conditions
- Retirement, Weight Gain
- Keywords
- Prevention, Retirement, Physical activity, Diet, Weight gain, Body composition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- Sep 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apparently healthy and recently retired
Key exclusion criteria (1 listed)
- Using drugs that might influence body composition, digestion or physical activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior change on physical activity and diet | Behavioural | – |
Primary outcome
Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure)
Energy intake (Food Frequency Questionnaire)
Physical activity level (Physical Activity Scale for the Elderly)
1 secondary outcome
Psychosocial factors (attitude, social influence, self-efficacy etc.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2010.
- Derived from this study: PubMed 20205704Werkman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evert G Schouten, PhD study chair
Wageningen University - Division of Human Nutrition
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavior change on physical activity and diet in people with Retirement and Weight Gain, run by Wageningen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2010; AzTrials last refreshed its copy on 30 Oct 2026.