NCT00862953

Brief Summary

This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2008

Typical duration 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

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

March 16, 2009

Last Update Submit

April 16, 2024

Conditions

Obesity

Keywords

low carbohydratehigh protein diet

Outcome Measures

Primary Outcomes (1)

  • Body weight

    1 year

Study Arms (4)

Normal protein normal carbohydrate

ACTIVE COMPARATOR

Normal protein normal carbohydrate calory restricted nutrition

Dietary Supplement: Normal protein energy-restricted

Normal protein low carbohydrates

EXPERIMENTAL

Normal protein low carbohydrate energy-restricted diet

Dietary Supplement: Normal protein energy-restricted

High protein normal carbohydrates

EXPERIMENTAL

High protein normal carbohydrates

Dietary Supplement: High protein energy-restricted

High protein low carbohydrate

EXPERIMENTAL

High protein low carbohydrate nutrition

Dietary Supplement: High protein energy-restricted

Interventions

Normal protein energy-restrictedDIETARY_SUPPLEMENT

Normal protein diet energy restricted

Normal protein low carbohydratesNormal protein normal carbohydrate
High protein energy-restrictedDIETARY_SUPPLEMENT

High protein diet, with either low or normal carbohydrate content

High protein low carbohydrateHigh protein normal carbohydrates

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity with BMI \> 27 kg/m2

You may not qualify if:

  • Recent loss of body weight (\>10%)
  • Underlying malignancy, HIV infection, psychiatric disease
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Hengelo

Hengelo, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • F NR Van Berkum, MD PhD

    Previtas Hengelo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

October 1, 2010

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

NL(1)