Weight LossNCT01724905
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
A study testing Modified Stop Light Diet (SLDm) and Recommended Care Diet in people with Weight Loss, run by Joseph Donnelly at 1 site in United States.
Trial summary
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Modified Stop Light Diet (SLDm) and Recommended Care Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)
- Able to understand and give informed consent
- If there is a guardian with power of attorney, both the guardian and participant must give informed consent
- Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation
- Overweight or obese determined by a BMI > 25 kg/m2
- Able to walk
- Clearance provided from physician
- Able to communicate preferences
Who cannot join
- Uncontrolled hypertension
- Severe heart disease
- Cancer diagnosis
- Positive for HIV
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.
The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.
- Conditions
- Weight Loss
- Being tested
- Modified Stop Light Diet (SLDm), Recommended Care Diet
- Keywords
- Diet, Obesity, Chronic disease
- Medical subject headings
- Weight Loss, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Stop Light Diet (SLDm)Dietary supplement
SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week
Recommended Care DietDietary supplement
RC diet includes traditional meal plans and 35 fruits and vegetables per week
| Study group | Role | What they receive |
|---|---|---|
| Modified Stop Light Diet | Experimental | Not described Receives: Dietary Supplement: Modified Stop Light Diet (SLDm) |
| Recommended Care for Weight Reduction | Active comparator | Not described Receives: Dietary Supplement: Recommended Care Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
Measured: Change from Baseline in Weight at 6 months
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
Measured: Change from Baseline in Weight at 18 months
Secondary outcomes (5)
Comparison of chronic disease factors - Blood Pressure
Changes in values of blood pressure between the two groups
Measured: Change from Baseline in Blood Pressure at 18 months
Comparison of chronic disease factors - Glucose
Changes in values of glucose between the two groups
Measured: Change from Baseline in Glucose at 18 months
Comparison of chronic disease factors - HDL
Changes in values of HDL-cholesterol between the two groups
Measured: Change from Baseline in HDL-cholesterol Pressure at 18 months
Comparison of chronic disease factors - LDL
Changes in values of LDL-cholesterol between the two groups
Measured: Change from Baseline in LDL-cholesterol Pressure at 18 months
Comparison of chronic disease factors - Insulin
Changes in values of insulin between the two groups
Measured: Change from Baseline in Insulin Pressure at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Donnelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Donnelly, University of Kansas Medical Center
- Investigators
- Joseph Donnelly, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724905
- Sponsor's protocol ID
- 18808
- Status last verified
- Dec 2015
- First submitted
- 1 Oct 2012
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ptomey LT, Willis EA, Sherman JR, White DA, Donnelly JE. Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching. J Intellect Disabil Res. 2020 Mar;64(3):221-233. doi: 10.1111/jir.12713. Epub 2020 Jan 15.
PubMed 31944472Ptomey LT, Steger FL, Lee J, Sullivan DK, Goetz JR, Honas JJ, Washburn RA, Gibson CA, Donnelly JE. Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities. J Acad Nutr Diet. 2018 Jun;118(6):1087-1096. doi: 10.1016/j.jand.2017.11.003. Epub 2018 Jan 6.
PubMed 29311038Ptomey LT, Willis EA, Lee J, Washburn RA, Gibson CA, Honas JJ, Donnelly JE. The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention. J Intellect Disabil Res. 2017 Aug;61(8):792-801. doi: 10.1111/jir.12392.
PubMed 28707359
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
- ClinicalTrials.gov ID
- NCT01724905
- Acronym / sponsor ID
- 18808
- Conditions
- Weight Loss
- Keywords
- Diet, Obesity, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Joseph DonnellyUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Nov 2012 (estimated)
- 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.
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.
The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Stop Light Diet | Experimental | Dietary Supplement: Modified Stop Light Diet (SLDm) |
| Recommended Care for Weight Reduction | Active comparator | Dietary Supplement: Recommended Care Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)
- Able to understand and give informed consent
- If there is a guardian with power of attorney, both the guardian and participant must give informed consent
- Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation
- Overweight or obese determined by a BMI > 25 kg/m2
Key exclusion criteria (4 listed)
- Uncontrolled hypertension
- Severe heart disease
- Cancer diagnosis
- Positive for HIV
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 |
|---|---|---|
| Modified Stop Light Diet (SLDm)SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week | Dietary supplement | Modified Stop Light Diet |
| Recommended Care DietRC diet includes traditional meal plans and 35 fruits and vegetables per week | Dietary supplement | Recommended Care for Weight Reduction |
Primary outcome
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
Time frame: Change from Baseline in Weight at 6 months
The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
Time frame: Change from Baseline in Weight at 18 months
The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
5 secondary outcomes
Comparison of chronic disease factors - Blood Pressure
Time frame: Change from Baseline in Blood Pressure at 18 months
Comparison of chronic disease factors - Glucose
Time frame: Change from Baseline in Glucose at 18 months
Comparison of chronic disease factors - HDL
Time frame: Change from Baseline in HDL-cholesterol Pressure at 18 months
Comparison of chronic disease factors - LDL
Time frame: Change from Baseline in LDL-cholesterol Pressure at 18 months
Comparison of chronic disease factors - Insulin
Time frame: Change from Baseline in Insulin Pressure at 18 months
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 14 Dec 2015.
- Derived from this study: PubMed 31944472Ptomey LT, Willis EA, Sherman JR, White DA, Donnelly JE. Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching. J Intellect Disabil Res. 2020 Mar;64(3):221-233. doi: 10.1111/jir.12713. Epub 2020 Jan 15.
- Derived from this study: PubMed 29311038Ptomey LT, Steger FL, Lee J, Sullivan DK, Goetz JR, Honas JJ, Washburn RA, Gibson CA, Donnelly JE. Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities. J Acad Nutr Diet. 2018 Jun;118(6):1087-1096. doi: 10.1016/j.jand.2017.11.003. Epub 2018 Jan 6.
- Derived from this study: PubMed 28707359Ptomey LT, Willis EA, Lee J, Washburn RA, Gibson CA, Honas JJ, Donnelly JE. The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention. J Intellect Disabil Res. 2017 Aug;61(8):792-801. doi: 10.1111/jir.12392.
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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.
Joseph Donnelly, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Stop Light Diet (SLDm) and Recommended Care Diet in people with Weight Loss, run by Joseph Donnelly at 1 site in United States.
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 8 inclusion and 4 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 14 Dec 2015. 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 United States. 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?
Weight loss between experimental diet (SLDm) and recommended care diet (RC) (time frame: Change from Baseline in Weight at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724905, which also lists 3 linked publications.
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 14 Dec 2015.