Dietary Intervention and Adults With Intellectual Disabil... | NCT04436692

Studies
Dietary Intervention and Adults With Intellectual Disabilities

NCT04436692

Sponsor

University of Oslo

Status

Completed

Last Update Posted

May 8, 2024Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Intellectual Disabilities Nutritional
Intellectual Disability

Interventions

Nudging

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jun 11, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Improve dietary pattern	Other	Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight	Behavioral: Nudging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nudging	Behavioral	Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables	Improve dietary pattern

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Mild intellectual disability and overweight
Moderate intellectual disability and overweight

Exclusion Criteria:

Metabolic diseases
Hypertension
Diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene F Andersen, PhD	Institute of Basic Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oslo		Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided