Childhood ObesityHelping HANDNCT01195012
Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND
A study testing Helping HAND (Healthy Nutrition and Activity Directions) in people with Childhood Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The program targets 5-8 year old children and their parents to change the child's lifestyle behaviors and the associated parenting practices to… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Helping HAND (Healthy Nutrition and Activity Directions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1) Child: Healthy 5 to 8 year old child who is overweight (BMI =/>85%), but not morbidly obese (BMI<99%)
- 2) Child attends one of 4 TCPA clinics
- 3) Child is Texas Children's Health Plan member/participant
- 4) Parent who is child's primary care taker able and willing to participate
- 5) Parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months
- 6) Only one child per family will be eligible to participate.
Who cannot join
- 1) Parent unable to read or write in English or Spanish.
- 2) Parent or child unable to participate in counseling sessions in English or Spanish
- 3) Child with BMI =/> 99%tile
- 4) Child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention.
- 5) Child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status
- 6) Child with medical problems that could influence their diet or physical activity or make it difficult for that child to participate in a behavior change program (such as mental retardation, neurologic disorders, severe food allergies or severe cardiac or pulmonary disease that restricts their activities).
- 7) Parents who participated in interviews during the developmental phase of Helping HAND
- 8) Family currently participating in other weight treatment of prevention programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND
This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The program targets 5-8 year old children and their parents to change the child's lifestyle behaviors and the associated parenting practices to improve the child's weight status. Four community clinics participated. Families were recruited from clinics and after informed consent and baseline data have been obtained, the families were randomized into one of two groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait list control group, who started the program 7 months later. Data were gathered on all the participating children and their parents at three time points: baseline, post the intervention (month 7) and post the wait list control group completing the intervention (month 14).
This was a pilot study to test the feasibility of an obesity prevention plus program delivered in the child's primary care clinic. The primary outcome was family attendance to the 3 data-collection meetings with research staff and the 6 prevention plus intervention sessions with a trained Health Advisor.
- Conditions
- Childhood Obesity
- Being tested
- Helping HAND (Healthy Nutrition and Activity Directions)
- Keywords
- child, primary care, treatment, parenting, lifestyle behaviors
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping HAND (Healthy Nutrition and Activity Directions)Behavioural
6-month behavioral intervention targeting 5-8 year old children and their parents to improve the child's lifestyle behaviors to improve their weight status. The families met monthly with trained Health Advisors for individual sessions in the pediatric clinic with phone calls in between visits to check on progress.
| Study group | Role | What they receive |
|---|---|---|
| wait-list control arm | Other | Participants wait-listed to start the behavioral obesity treatment program (Helping HAND) after time two data collection (7 months after baseline). Receives: Behavioral: Helping HAND (Healthy Nutrition and Activity Directions) |
| Intervention arm | Experimental | see intervention description Receives: Behavioral: Helping HAND (Healthy Nutrition and Activity Directions) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJul 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 Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresia O'Connor, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195012
- Sponsor's protocol ID
- BCM-H-22657
- Acronym
- Helping HAND
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2010
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connor TM, Hilmers A, Watson K, Baranowski T, Giardino AP. Feasibility of an obesity intervention for paediatric primary care targeting parenting and children: Helping HAND. Child Care Health Dev. 2013 Jan;39(1):141-9. doi: 10.1111/j.1365-2214.2011.01344.x. Epub 2011 Nov 9.
PubMed 22066521
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND
- ClinicalTrials.gov ID
- NCT01195012
- Acronym / sponsor ID
- Helping HAND / BCM-H-22657
- Conditions
- Childhood Obesity
- Keywords
- child, primary care, treatment, parenting, lifestyle behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Sep 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.
This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The program targets 5-8 year old children and their parents to change the child's lifestyle behaviors and the associated parenting practices to improve the child's weight status. Four community clinics participated. Families were recruited from clinics and after informed consent and baseline data have been obtained, the families were randomized into one of two groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait list control group, who started the program 7 months later. Data were gathered on all the participating children and their parents at three time points: baseline, post the intervention (month 7) and post the wait list control group completing the intervention (month 14).
This was a pilot study to test the feasibility of an obesity prevention plus program delivered in the child's primary care clinic. The primary outcome was family attendance to the 3 data-collection meetings with research staff and the 6 prevention plus intervention sessions with a trained Health Advisor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wait-list control arm | Other | Behavioral: Helping HAND (Healthy Nutrition and Activity Directions)Participants wait-listed to start the behavioral obesity treatment program (Helping HAND) after time two data collection (7 months after baseline). |
| Intervention arm | Experimental | Behavioral: Helping HAND (Healthy Nutrition and Activity Directions)see intervention description |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 1) Child: Healthy 5 to 8 year old child who is overweight (BMI =/>85%), but not morbidly obese (BMI<99%)
- 2) Child attends one of 4 TCPA clinics
- 3) Child is Texas Children's Health Plan member/participant
- 4) Parent who is child's primary care taker able and willing to participate
- 5) Parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months
Key exclusion criteria (8 listed)
- 1) Parent unable to read or write in English or Spanish.
- 2) Parent or child unable to participate in counseling sessions in English or Spanish
- 3) Child with BMI =/> 99%tile
- 4) Child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention.
- 5) Child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status
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 |
|---|---|---|
| Helping HAND (Healthy Nutrition and Activity Directions)6-month behavioral intervention targeting 5-8 year old children and their parents to improve the child's lifestyle behaviors to improve their weight status. The families met monthly with trained Health Advisors for individual sessions in the pediatric clinic with phone calls in between visits to check on progress. | Behavioural | Intervention arm, wait-list control arm |
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 9 Mar 2020.
- Results publication: PubMed 22066521O'Connor TM, Hilmers A, Watson K, Baranowski T, Giardino AP. Feasibility of an obesity intervention for paediatric primary care targeting parenting and children: Helping HAND. Child Care Health Dev. 2013 Jan;39(1):141-9. doi: 10.1111/j.1365-2214.2011.01344.x. Epub 2011 Nov 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helping HAND (Healthy Nutrition and Activity Directions) in people with Childhood Obesity, run by Baylor College of Medicine 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 8 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 9 Mar 2020. 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 NCT01195012, 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 9 Mar 2020.