NCT04436692

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

June 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

June 11, 2020

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight by using a nudging approach in adults with intellectual disabilities

    2 kg weight decrease

    One year

Secondary Outcomes (1)

  • Change in consumption of fruits and vegetables as measured using dietary survey

    One year

Other Outcomes (1)

  • Change in consumption of sugar containing beverages as measured using dietary survey

    One year

Study Arms (1)

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

NudgingBEHAVIORAL

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

Improve dietary pattern

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Metabolic diseases
  • Hypertension
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lene F Andersen, PhD

    Institute of Basic Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 18, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 8, 2024

Record last verified: 2023-05

Locations