Down SyndromeNCT01256112
Parent Supported Weight Reduction in Down Syndrome
A study testing Parent Supported Behavioral Intervention and Nutrition/Activity Education (NAE) in people with Down Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavioral lifestyle change strategies are added. Read more about this study
- Who is it for?
- Ages 13 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Parent Supported Behavioral Intervention and Nutrition/Activity Education (NAE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2010
- 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 13 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 13-26 with Down syndrome
- Living at home in single- or two-parent family, w/no plans to leave home in next year
- Achieves IQ score 45 or above on the Kaufman Brief Intelligence Test (K-BIT)
- Academic ability and necessary behavioral/social control to participate in a group classroom-based educational program
- Clinically overweight, as indicated by a BMI at or above 85th percentile for age and gender
- Signed approval to participate, which includes a completed recent thyroid screen, provided by participant's Primary Physician (and participant's cardiologist is he/she has a history of a heart condition), and participant's neurologist if he/she has a history of seizures)
Who cannot join
- Untreated thyroid disorder
- Type I or II Diabetes
- Cardiac problem, treated or untreated, for whom the participant's treating cardiologist indicates restrictions in physical activity
- Epilepsy/seizure disorder in which participant is not stable on medications
- Orthopedic injuries or deformities
- Chronic GI illness (except constipation) including inflammatory bowel diseases and celiac disease
Show all 16Show fewer
- Prader Willi syndrome
- Unwillingness to wear accelerometer at screening or enrollment
- Non-ambulatory, i.e., uses wheelchair or other assistive devices for moving about and walking
- Chronic/severe foot infection (as screened by physical therapist, but in coordination with physician)
- Severe balance problems (as screened by physical therapist)
- Resting heart rate less than 50 beats per minute (bpm), or greater to or equal to 100 bpm (observed in physical therapy screening)
- History of major medical illness (i.e., cancer, leukemia)
- History of profound behavioral problems, i.e., self injury, injury to others, property destruction, etc.
- Other diagnosed disorders, including autism spectrum disorders, bipolar disorder (within the last year), eating disorder (within the last year), major depression (within the last year), psychosis \& schizophrenia
- Other exclusion conditions left to the discretion of the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
Eunice Kennedy Shriver Center at UMASS Medical School
Waltham, Massachusetts, 02452
About this study
The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavioral lifestyle change strategies are added.
Read the detailed description
Children with intellectual disabilities, including Down syndrome (DS), are as likely to be overweight than their typically developing peers. The consequences of childhood obesity include increased risk for Type-2 diabetes, orthopedic problems, sleep apnea, elevated cardiovascular risk and menstrual irregularities. Research indicating a high prevalence of overweight, obesity, low fitness levels and other health problems among adults with DS suggest the need for more attention to health promotion among adolescents with DS, which has been limited to date. Educational interventions in nutrition and physical activity have not been tested through randomized clinical trial with families of adolescents with DS; nor have behavioral "lifestyle change" interventions based on Social Cognitive Theory. Among typical populations, the addition of training in behavior and lifestyle change to education-alone interventions increasingly is being seen as critical in helping to promote long-term weight loss and weight maintenance. The hypothesis of this study is that a parent supported weight reduction (PSWR) intervention that combines behavioral strategies with nutrition and activity education (NAE) will be more effective in reducing overweight in adolescents with DS than a program that provides NAE alone or a Wait-List (WL) control.
- Conditions
- Down Syndrome
- Being tested
- Parent Supported Behavioral Intervention, Nutrition/Activity Education (NAE)
- Keywords
- obesity, behavioral intervention, family based, weight loss
- Medical subject headings
- Down Syndrome, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Supported Behavioral InterventionBehavioural
Also called lifestyle modification, behavior modification, behavior therapy
Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.
Nutrition/Activity Education (NAE)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| NAE + Behavioral Intervention | Experimental | Parents of participants receive training in behavioral support at home, in addition to a standard nutrition and physical activity education (NAE) program. Receives: Behavioral: Parent Supported Behavioral Intervention; Behavioral: Nutrition/Activity Education (NAE) |
| Nutrition/Activity Education | Active comparator | Parents and participants receive a standard nutrition and physical activity education (NAE) program. Receives: Behavioral: Nutrition/Activity Education (NAE) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startSep 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Richard K Fleming, PhD, Principal investigator, University of Massachusetts Medical School, Eunice Kennedy Shriver Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256112
- Sponsor's protocol ID
- 1 R03 DK070627 (completed)
- Other IDs
- R03DK070627
- Status last verified
- Oct 2017
- First submitted
- 6 Dec 2010
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Curtin C, Bandini LG, Must A, Gleason J, Lividini K, Phillips S, Eliasziw M, Maslin M, Fleming RK. Parent support improves weight loss in adolescents and young adults with Down syndrome. J Pediatr. 2013 Nov;163(5):1402-8.e1. doi: 10.1016/j.jpeds.2013.06.081. Epub 2013 Aug 20.
PubMed 23968742
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Supported Weight Reduction in Down Syndrome
- ClinicalTrials.gov ID
- NCT01256112
- Acronym / sponsor ID
- 1 R03 DK070627 (completed)
- Conditions
- Down Syndrome
- Keywords
- obesity, behavioral intervention, family based, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Sep 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Dec 2010 (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.
The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavioral lifestyle change strategies are added.
Detailed description
Children with intellectual disabilities, including Down syndrome (DS), are as likely to be overweight than their typically developing peers. The consequences of childhood obesity include increased risk for Type-2 diabetes, orthopedic problems, sleep apnea, elevated cardiovascular risk and menstrual irregularities. Research indicating a high prevalence of overweight, obesity, low fitness levels and other health problems among adults with DS suggest the need for more attention to health promotion among adolescents with DS, which has been limited to date. Educational interventions in nutrition and physical activity have not been tested through randomized clinical trial with families of adolescents with DS; nor have behavioral "lifestyle change" interventions based on Social Cognitive Theory. Among typical populations, the addition of training in behavior and lifestyle change to education-alone interventions increasingly is being seen as critical in helping to promote long-term weight loss and weight maintenance. The hypothesis of this study is that a parent supported weight reduction (PSWR) intervention that combines behavioral strategies with nutrition and activity education (NAE) will be more effective in reducing overweight in adolescents with DS than a program that provides NAE alone or a Wait-List (WL) control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAE + Behavioral Intervention | Experimental | Behavioral: Parent Supported Behavioral Intervention, Behavioral: Nutrition/Activity Education (NAE)Parents of participants receive training in behavioral support at home, in addition to a standard nutrition and physical activity education (NAE) program. |
| Nutrition/Activity Education | Active comparator | Behavioral: Nutrition/Activity Education (NAE)Parents and participants receive a standard nutrition and physical activity education (NAE) program. |
Who may qualify
- Ages
- 13 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 13-26 with Down syndrome
- Living at home in single- or two-parent family, w/no plans to leave home in next year
- Achieves IQ score 45 or above on the Kaufman Brief Intelligence Test (K-BIT)
- Academic ability and necessary behavioral/social control to participate in a group classroom-based educational program
- Clinically overweight, as indicated by a BMI at or above 85th percentile for age and gender
Key exclusion criteria (16 listed)
- Untreated thyroid disorder
- Type I or II Diabetes
- Cardiac problem, treated or untreated, for whom the participant's treating cardiologist indicates restrictions in physical activity
- Epilepsy/seizure disorder in which participant is not stable on medications
- Orthopedic injuries or deformities
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 |
|---|---|---|
| Parent Supported Behavioral InterventionAlso: lifestyle modification, behavior modification, behavior therapyParents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss. | Behavioural | NAE + Behavioral Intervention |
| Nutrition/Activity Education (NAE) | Behavioural | NAE + Behavioral Intervention, Nutrition/Activity Education |
Primary outcome
Not reported in the source record.
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 18 Oct 2017.
- Results publication: PubMed 23968742Curtin C, Bandini LG, Must A, Gleason J, Lividini K, Phillips S, Eliasziw M, Maslin M, Fleming RK. Parent support improves weight loss in adolescents and young adults with Down syndrome. J Pediatr. 2013 Nov;163(5):1402-8.e1. doi: 10.1016/j.jpeds.2013.06.081. Epub 2013 Aug 20.
- Web site for organization in which research was conductedLink provided by the sponsor.
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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.
Richard K Fleming, PhD principal investigator
University of Massachusetts Medical School, Eunice Kennedy Shriver 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 Parent Supported Behavioral Intervention and Nutrition/Activity Education (NAE) in people with Down Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 16 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 18 Oct 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256112, which also lists 1 linked publication.
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 18 Oct 2017.