Clincosm LogoSign in Get a demo

Dietary Intervention and Adults With Intellectual Disabilities

Sponsor
University of Oslo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04436692
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
28
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nudging
 N/A

Detailed Description

Purpose

There are two main purposes of the study The first is to study the diet and heath of persons with intellectual disabilities. The second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. Physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. A combined study with many changes in a short period of time is very challenging for the group in question.

The vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Improve dietary pattern

Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight

Behavioral: Nudging
Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables

Outcome Measures

Primary Outcome Measures

  1. Change in body weight by using a nudging approach in adults with intellectual disabilities [One year]

    2 kg weight decrease

Secondary Outcome Measures

  1. Change in consumption of fruits and vegetables as measured using dietary survey [One year]

    Dietary change 1

Other Outcome Measures

  1. Change in consumption of sugar containing beverages as measured using dietary survey [One year]

    Dietary change 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Mild intellectual disability and overweight

  • Moderate intellectual disability and overweight

Exclusion Criteria:

  • Metabolic diseases

  • Hypertension

  • Diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oslo Oslo Norway

Sponsors and Collaborators

  • University of Oslo

Investigators

  • Study Chair: Lene F Andersen, PhD, Institute of Basic Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Svein Olav Kolset, Professor, University of Oslo
ClinicalTrials.gov Identifier:
NCT04436692
Other Study ID Numbers:
  • Department of Nutrition
First Posted:
Jun 18, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intellectual Disability

Study Results

No Results Posted as of Apr 6, 2022