Back to resultsDietary Intervention and Adults With Intellectual Disabilities
Primary Purpose
Intellectual Disabilities Nutritional, Intellectual Disability
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nudging
Sponsored by
About this trial
This is an interventional health services research trial for Intellectual Disabilities Nutritional
Eligibility Criteria
Inclusion criteria:
- Mild intellectual disability and overweight
- Moderate intellectual disability and overweight
Exclusion Criteria:
- Metabolic diseases
- Hypertension
- Diabetes
Sites / Locations
- University of OsloRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Improve dietary pattern
Arm Description
Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight
Outcomes
Primary Outcome Measures
Change in body weight by using a nudging approach in adults with intellectual disabilities
2 kg weight decrease
Secondary Outcome Measures
Change in consumption of fruits and vegetables as measured using dietary survey
Dietary change 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04436692
Brief Title
Dietary Intervention and Adults With Intellectual Disabilities
Official Title
Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disabilities Nutritional, Intellectual Disability
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Improve dietary pattern
Arm Type
Other
Arm Description
Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight
Intervention Type
Behavioral
Intervention Name(s)
Nudging
Intervention Description
Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables
Primary Outcome Measure Information:
Title
Change in body weight by using a nudging approach in adults with intellectual disabilities
Description
2 kg weight decrease
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change in consumption of fruits and vegetables as measured using dietary survey
Description
Dietary change 1
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Change in consumption of sugar containing beverages as measured using dietary survey
Description
Dietary change 2
Time Frame
One year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Mild intellectual disability and overweight
Moderate intellectual disability and overweight
Exclusion Criteria:
Metabolic diseases
Hypertension
Diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Svein O Kolset, PhD
Phone
+47 22851383
Email
s.o.kolset@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Nordstrøm, PhD
Phone
+4764856047
Email
marianne.nordstrom@frambu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene F Andersen, PhD
Organizational Affiliation
Institute of Basic Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helel K Røstad-Tollefsen, MSc
Phone
+4799011566
Email
helen.k.r.tollefsen@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Dietary Intervention and Adults With Intellectual Disabilities
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