Intellectual Disabilities NutritionalNCT04436692
Dietary Intervention and Adults With Intellectual Disabilities
A study testing Nudging in people with Intellectual Disabilities Nutritional and Intellectual Disability, run by University of Oslo at 1 site in Norway.
Trial summary
Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intellectual Disabilities Nutritional, Intellectual Disability
- What is being tested?
- Nudging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mild intellectual disability and overweight
- Moderate intellectual disability and overweight
Who cannot join
- Metabolic diseases
- Hypertension
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Nudging
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgingBehavioural
Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Nudging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight by using a nudging approach in adults with intellectual disabilities
2 kg weight decrease
Measured: One year
Secondary outcomes (1)
Change in consumption of fruits and vegetables as measured using dietary survey
Dietary change 1
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disabilities NutritionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Olav Kolset, University of Oslo
- Investigators
- Lene F Andersen, PhD, Study chair, Institute of Basic Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436692
- Sponsor's protocol ID
- Department of Nutrition
- Status last verified
- May 2023
- First submitted
- 11 Jun 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method
- ClinicalTrials.gov ID
- NCT04436692
- Acronym / sponsor ID
- Department of Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improve dietary pattern | Other | Behavioral: NudgingNudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mild intellectual disability and overweight
- Moderate intellectual disability and overweight
Key exclusion criteria (3 listed)
- Metabolic diseases
- Hypertension
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NudgingUse nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables | Behavioural | Improve dietary pattern |
Primary outcome
Change in body weight by using a nudging approach in adults with intellectual disabilities
Time frame: One year
2 kg weight decrease
1 secondary outcome
Change in consumption of fruits and vegetables as measured using dietary survey
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene F Andersen, PhD study chair
Institute of Basic Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudging in people with Intellectual Disabilities Nutritional and Intellectual Disability, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight by using a nudging approach in adults with intellectual disabilities (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.