Dietary Intervention and Adults With Intellectual Disabilities

April 5, 2022 updated by: Svein Olav Kolset, University of Oslo

Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Mild intellectual disability and overweight
  • Moderate intellectual disability and overweight

Exclusion Criteria:

  • Metabolic diseases
  • Hypertension
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight by using a nudging approach in adults with intellectual disabilities
Time Frame: One year
2 kg weight decrease
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in consumption of fruits and vegetables as measured using dietary survey
Time Frame: One year
Dietary change 1
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in consumption of sugar containing beverages as measured using dietary survey
Time Frame: One year
Dietary change 2
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Department of Nutrition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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