Metabolic SyndromeNCT03139214
Parenting Intervention and Metabolic Syndrome
A study testing Parenting Intervention in people with Metabolic Syndrome, run by Northwestern University.
Trial summary
This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Parenting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2001to 30 Dec 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- -
About this study
This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.
Read the detailed description
In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.
- Conditions
- Metabolic Syndrome
- Being tested
- Parenting Intervention
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parenting intervention, 7 weekly sessions, each session 2 hours in length. Receives: Behavioral: Parenting Intervention |
| Control | No intervention | 3 mailings about child development and stress management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)
Metabolic syndrome diagnosis
Measured: 14 years post-intervention
Metabolic syndrome components
Number of components of metabolic syndrome that were clinically elevated
Measured: 14 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start27 Aug 2001
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139214
- Sponsor's protocol ID
- STUDY00000856
- Status last verified
- May 2017
- First submitted
- 28 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Intervention and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03139214
- Acronym / sponsor ID
- STUDY00000856
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Georgia
- Study start
- 27 Aug 2001 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 3 May 2017 (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.
This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.
Detailed description
In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Parenting InterventionParenting intervention, 7 weekly sessions, each session 2 hours in length. |
| Control | No intervention | –3 mailings about child development and stress management. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Parenting Intervention | Behavioural | Intervention |
Primary outcome
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose)
Time frame: 14 years post-intervention
Metabolic syndrome diagnosis
Metabolic syndrome components
Time frame: 14 years post-intervention
Number of components of metabolic syndrome that were clinically elevated
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 3 May 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Intervention in people with Metabolic Syndrome, run by Northwestern University.
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 0 inclusion and 1 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose) (time frame: 14 years post-intervention). 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?
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 3 May 2017.