Preventing Obesity through Parent Empowerment and the Activation of Routines for Down Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Down Syndrome Center of Western Pennsylvania, Pittsburgh, PA
Down Syndrome
Preventing Obesity through Parent Empowerment and the Activation of Routines - Behavioral
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a set of activities can improve sleep habits in people with dementia.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Preventing Obesity through Parent Empowerment and the Activation of Routines will improve 5 primary outcomes and 12 secondary outcomes in patients with Down Syndrome. Measurement will happen over the course of baseline to 3 months.

3 months
Interventionist fidelity to treatment protocol
Number of PrO-PEAR intervention sessions completed
Parent-reported intervention acceptability as rated on a Likert scale.
6 months
Percentage of planned data collection efforts completed successfully
baseline to 1 year
Change in Child Height from Baseline to 1 year
Change in Child Weight from Baseline to 1 year
baseline to 3 months
Change in Healthy Eating from Baseline to 3 months
Change in Physical Activity from Baseline to 3 months
Change in Sedentary Behavior from Baseline to 3 months
Change in Sleep Quality form Baseline to 3 months
baseline to 6 months
Change in Child Height from Baseline to 6 months
Change in Child Weight from Baseline to 6 months
Change in Healthy Eating from Baseline to 6 months
Change in Physical Activity from Baseline to 6 months
Change in Sedentary Behavior from Baseline to 6 months
Change in Sleep Quality form Baseline to 6 months
up to 1 year
Number of participant families recruited per month

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Enhanced Usual Care
1 of 2
PrO-PEAR
1 of 2
Active Control
Experimental Treatment

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Preventing Obesity Through Parent Empowerment And The Activation Of Routines is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PrO-PEAR
Behavioral
This group will receive the optimized PrO-PEAR intervention (in addition to usual care).
Enhanced Usual Care
Behavioral
This group will serve as the control group and only receive a report of their child's performance and adherence to World Health Organization recommendations based on baseline data.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year for reporting.

Who is running the study

Principal Investigator
A. C.
Prof. Angela Caldwell, Assistant Professor
University of Pittsburgh

Closest Location

Down Syndrome Center of Western Pennsylvania - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
between the ages of 12 and 36 months
The doctors diagnosed the baby with Down syndrome. show original
The baby can demonstrate their ability to walk or crawl on their own. show original
Child

Patient Q&A Section

What are common treatments for down syndrome?

"When treating a child with an extra X and a Y chromosome, the prenatal diagnosis of Y-partial monosomy 21 is indicated to provide an appropriately tailored plan to treat the child to optimize outcomes. An interdisciplinary team approach is needed for both the prenatal and perinatal care of these children." - Anonymous Online Contributor

Unverified Answer

What are the signs of down syndrome?

"Down syndrome may be characterized by: small hands and fingers, poor muscle tone, small stomach, flat chest, curved spine, small head, and short legs. Down syndrome can manifest in other body parts as well, but its most noticeable signs are the characteristic facial features. \n- Down Syndrome and Behavioral and Neurodevelopmental\n- Down Syndrome and Mental Health Care"

"Château César-Beaune Grand Cru\n\nBeaune Grand Cru is a grand vin designation used for red wine made and aged through traditional oak aging in the region of Côte-d'Or; it is the most prestigious designation in France." - Anonymous Online Contributor

Unverified Answer

What causes down syndrome?

"While still under investigation, the prevailing theory seems to be that trisomy 21 is caused by a nondominant reciprocal translocation, which produces a derivative chromosome and removes the functional copies of chromosome 21. Although the mechanism by which this occurs is still unclear, two lines of evidence suggest it may not be random. First, Down syndrome is extremely rare in some populations of African descent, where trisomic chromosomes are the most common and may be more prevalent among parents whose first pregnancies have been induced than among parents of primiparous women." - Anonymous Online Contributor

Unverified Answer

How many people get down syndrome a year in the United States?

"Approximately 2.3 million children between the ages of 1 and 21 years have Down syndrome in the United States and approximately 175,000 children with Down syndrome are living in California. Based on these numbers, there are approximately one tenth as many boys with Down syndrome as there are girls with Down syndrome in the United States." - Anonymous Online Contributor

Unverified Answer

Can down syndrome be cured?

"Down syndrome cannot be cured. Although a subset of patients with Down syndrome can lead very active lives, a cure for their condition is not a realistic expectation." - Anonymous Online Contributor

Unverified Answer

What is down syndrome?

"DS is caused by a chromosome 21 trisomy, most often occurring because of nondisjunction of one of the maternal chromosomes in the first division of meiosis. About 65% of men with DS develop intellectual disabilities; intellectual disabilities are found in about 96% of women who conceive and carry a baby with DS. The main manifestations are learning disabilities (dyscalculia, alexia, or receptive language disorder), and social and behavioural problems (antisocial behaviours). DS is a syndrome, although it is often considered as a single disease. This could be an issue as it contributes to a decreased ability to understand and deal with an array of adverse effects from their surroundings." - Anonymous Online Contributor

Unverified Answer

Is preventing obesity through parent empowerment and the activation of routines typically used in combination with any other treatments?

"Parents and parents of individuals with DS should be informed on their child's risk of obesity. The intervention programme should be focused on mothers and parents. Parents should be made aware of the strategies that can be used to prevent obesity in their children, and their children have to be educated on health-related issues, on their personal rights, and on the use of electronic media. This intervention should be done routinely, with more emphasis on mothers and families due to their larger influence as main carriers of the disease." - Anonymous Online Contributor

Unverified Answer

How serious can down syndrome be?

"This information is an attempt to raise questions about the attitudes and awareness of the public and health professionals toward these syndromes. Clearly people have been seriously affected by down syndrome, with major psychiatric and neurologic complications. But it appears that the public are not yet fully aware or aware of the serious side-effects. We feel that public awareness campaigns and health information about DS would be helpful. Clearly it would be desirable to raise awareness to the health and medical professionals who are directly involved in a patient’s care and to raise public awareness of the seriousness of both syndromes. Clearly, more emphasis should be placed on community, as well as patient health education." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating down syndrome?

"There have been some new findings for treating Down syndrome. The first treatment was the prenatal treatment before birth to help the baby during the first month. Later research was done to use early cranial ultrasound which can help detect heart problems and help with treatment. The second type of treatment includes using Vitamin E and vitamin D tablets orally three times a week. It aids in the development of nerves and muscle and brain. The third type of treatment helps in relieving some symptoms of the infant. There are several drugs and medications taken to help the child with certain symptoms. It is up to the mother of the person with Down's Syndrome to decide what medical treatments are appropriate. There are several different places where you can get treatment of your own." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets down syndrome?

"To the best of our knowledge, the latest international report with standardized case definitions in the field is a 2007 publication from Japan. That is the largest cohort of patients with down syndrome from any country analyzed. The average age of diagnosis of the T21-M45-D18/T21-D18-D19 cohort in Japan in 2004 was 41.0 years for females and 43.2 for males. The average age of diagnosis of other subtypes by this study is significantly earlier. Approximately a half of the patients diagnosed were 25 years or younger. T21-D18/T21-D19 is the most common subtype and the least severe. The average age of diagnosis was 48.9 years for females and 54." - Anonymous Online Contributor

Unverified Answer

What is the latest research for down syndrome?

"There is very little research in the last 20 years; thus, all information about it is of an outdated nature. I’m glad that there hasn’t yet been research into how much brain damage Down syndrome causes. People with Down syndrome live into their 60s, and they are just like any other 65-year-old! I wish I wasn’t, when I’d be dead." - Anonymous Online Contributor

Unverified Answer

Does preventing obesity through parent empowerment and the activation of routines improve quality of life for those with down syndrome?

"Although health care providers could promote weight control with routine health promotion and parent empowerment, the children with DS who did this without their parents (and without regular health care) had better quality of life." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Down Syndrome by sharing your contact details with the study coordinator.