Mothers and Girls Dancing Together Trial (MAGNET)

June 7, 2023 updated by: Sofiya Alhassan, University of Massachusetts, Amherst

Effects of an Afro-centric Dance Program for African-American Daughters and Mothers

The purpose of this study is to examine the feasibility and efficacy of a 12-week afterschool afro-centric dance physical activity program for daughters and mothers on the physical activity level of African-American girls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Like African-American women, African-American girls suffer disproportionately from obesity and Type 2 diabetes mellitus. One factor strongly associated with the development of obesity and Type 2 diabetes mellitus disparities in children is low physical activity levels. Low physical activity is more prevalent in African-American girls, pointing to the critical need for effective physical activity interventions. For a physical activity intervention message to be effective among African-American girls, the program must be enjoyable and tailored to African-American girls and women. One possibility for an appropriate physical activity intervention is afro-centric dance, which has strong cultural and historical significance in the African-American community. This form of physical activity may provide girls with sustained bouts of moderate-to-vigorous physical activity. There appears to be a strong positive correlation between parental and children physical activity levels. In the African-American culture, maternal health behaviors in particular have a strong influence on children's health behaviors. Currently, there are no studies that examine the effects of a daughter-mother Afro-centric dance program on the physical activity levels of African-American girls. Therefore, the purpose of this study will be to examine the feasibility and efficacy of a 12-week physical activity intervention consisting of afro-centric dance and its ability to affect the physical activity levels of African-American girls. If investigators identify afro-centric dance as a sustainable form of physical activity for African-American daughters and mothers, investigators can use this intervention to significantly reduce obesity and Type 2 diabetes mellitus in these groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Organizations, Churches, and Elementary Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Girls:

  • 7 -10 yrs old on the date of randomization
  • Defined as African-American if her parent/guardian identifies her as such
  • No inclusion criteria will be used for mothers

Exclusion Criteria:

  • Unable to wear the activity monitor
  • Unable to participate in physical activity, require oxygen supplementation for exertion, have a developmental or physical disability preventing participation, cannot increase their physical activity for any reason, uncorrected structural heart disease)
  • If girl and/or mother is unable to read, understand, or complete the informed consent or surveys in English.
  • Musculoskeletal injuries or disorders that would prevent participation
  • Taking diabetes (type 1 or 2), renal diseases, eating disorder, pregnancy medication
  • Take medications affecting growth (e.g., insulin, oral hypoglycemic, thyroid hormone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Girls and mothers dance together
African-American girls AND their mom's will participate in the Afro-centric dance program together and also receive weekly newsletter that focuses on health related issues.
Behavioral: Girls and mothers Afro-centric dance program
African-American girls and their mom's will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information.
Other Names:
  • Girls and mothers, together
Experimental: Girls, alone
African-American girls will participate in the Afro-centric dance program alone. Girls and mom's will receive weekly newsletter that focuses on health related issues
Behavioral: Girls, alone
African-American girls (without their mom's) will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information.
Active Comparator: No dancing
African-American girls and their mom's will only receive weekly newsletter that focuses on health related issues.
Other: Newsletter
Both girls and the mothers will receive weekly newsletter containing various health information.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in physical activity level at 12-weeks
Time Frame: Baseline, 6-weeks and 12-weeks after study initiation
Baseline, 6-weeks and 12-weeks after study initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in body mass index, fasting insulin, and psychosocial
Time Frame: Baseline and 12-weeks after the initiation of the study protocol
Baseline and 12-weeks after the initiation of the study protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sofiya Alhassan, PhD, University of Massachusetts, Amherst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-0804

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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