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

Weight Gain Clinical Trial

Official title:

An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122213
• Other study ID #: 2000T205
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2005
• Last updated: April 20, 2010
• Start date: September 2003
• Est. completion date: February 2006

Study information

• Verified date: April 2010
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• Apparently healthy and recently retired

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Retirement
• Weight Gain

Intervention

Behavioral:
• Behavior change on physical activity and diet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Netherlands Heart Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure)
Primary	Energy intake (Food Frequency Questionnaire)
Primary	Physical activity level (Physical Activity Scale for the Elderly)
Secondary	Psychosocial factors (attitude, social influence, self-efficacy etc.)