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Diabetes Mellitus, Type 2ADAPTNCT03159221

Behavioral Family Systems Therapy (BFST) for Teens With Type 2 Diabetes

A study testing BFST for Teens with Type 2 Diabetes in people with Diabetes Mellitus, Type 2 and Childhood Obesity, run by Nemours Children's Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet the needs of teens with type 2 diabetes. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 2, Childhood Obesity
What is being tested?
BFST for Teens with Type 2 Diabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Apr 2011to Jul 2016
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 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosed with type 2 diabetes mellitus for 6 months or more
  • Age-adjusted Body Mass Index at or above the 85th percentile (considered overweight)
  • Established diabetes care in Nemours Children's Clinic system or diabetes care meets minimum criteria for current American Diabetes Association Standards.
  • Adolescent lives at home in the study geographical area (Jacksonville, FL)over the course of the study duration (one year).
  • One caregiver in the home is willing to participate in the family intervention.

Who cannot join

  • Adolescent has another systemic chronic disease other than well-controlled asthma.
  • Genetic syndrome or disorder (other than diabetes) known to affect glucose tolerance.
  • Daily use of glucocorticoids or other medications known to affect glucose tolerance.
  • Teen is enrolled in special education for students who have autism or are mentally handicapped.
  • Adolescent is pregnant or planning to be pregnant within 1 year.
  • Teen resides in temporary foster care, group home, or juvenile detention center.
  • The family has an open case with an agency investigating child abuse or neglect.
  • Adolescent has been in an inpatient psychiatric facility or substance abuse treatment in the past 6 months.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nemours Children's Specialty Care

    Jacksonville, Florida, 32207

Other trials in United States

About this study

Official title: Behavioral Family Systems Therapy for Teens With Type 2 Diabetes: A Pilot

This is a randomized, controlled pilot trial of Behavioral Family Systems Therapy for Teens with Type 2 Diabetes (BFST-DM2), an individual psychological intervention tailored to meet the needs of teens with type 2 diabetes. It is hypothesized that this behavioral family intervention will be feasible to implement with teens with type 2 diabetes and will have positive effects on treatment adherence, health outcomes like weight status and metabolic control, and psychological outcomes.

Read the detailed description

The incidence of type 2 diabetes mellitus (DM2) in youth is increasing dramatically with the rise in obesity in the U.S. and worldwide. DM2 in youth, as with adults, is clearly linked to modifiable risk factors such as obesity, sedentary lifestyle, and poor diet. Youth with DM2 are at increased risk for medical complications such as cardiovascular disease, retinopathy, and neuropathy, as well as psychological problems such as depression, anxiety, poor self-esteem, eating disorders, and poor coping and problem solving. Although there are studies demonstrating that family-based lifestyle and psychological interventions are successful in reducing obesity in youth and in improving metabolic control and adherence in youth with type 1 diabetes mellitus (DM1), very little has been published on potential lifestyle or psychological treatments for youth with DM2. Studies have shown that Behavioral Family Systems Therapy (BFST) has been effective in improving metabolic control, adherence, family communication, and problem solving in youth with DM1. This intervention could be effective in treating youth with DM2, as many of the skills necessary for good metabolic control, health outcomes, treatment adherence, and psychological adjustment are similar in both populations. This application proposes a randomized, controlled pilot trial of BFST-DM2, an individual psychological intervention tailored to meet the needs of teens with DM2. BFST will be adapted to make this intervention more feasible and relevant with minority and low-income populations and also to focus on weight management, exercise, and nutrition. The BFST-DM2 intervention includes 12 (90-minute) sessions over 6 months. Areas targeted for improvement will include metabolic control, weight/body mass index, treatment adherence, family lifestyle choices (activity, diet), family communication, and problem solving. One of the main aims of this pilot study is to gather exploratory information on the effectiveness of the BFST-DM2 intervention on measures of health outcomes, medical adherence, lifestyle changes, and family problem-solving and communication skills. In addition, it is an aim to estimate treatment effect size to determine the sample size needed to power a larger multi-site trial of the BFST-DM2 intervention. Other aims include determining factors associated with feasibility (recruitment, retention, participation, generalizability) as well as to modify the intervention to be culturally sensitive and to be more relevant to the individual needs of the DM2 adolescent population. The BFST-DM2 intervention will be compared with standard medical therapy on measures of health outcomes (metabolic control, body mass index, weight, waist circumference, body fat) physical activity (accelerometer), nutritional intake, treatment adherence, psychological adjustment (self-esteem, quality of life), family communication, and problem solving. The researchers will analyze predictors of treatment outcome and the treatment effects at the immediate post-treatment interval (6 months from baseline). Health outcomes and medical adherence data also will be collected 12 months from baseline to determine maintenance of treatment effects over time.

Being tested
BFST for Teens with Type 2 Diabetes
Keywords
type 2 diabetes in adolescents, obesity in adolescents, behavioral family systems therapy
Medical subject headings
Diabetes Mellitus, Type 2, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BFST for Teens with Type 2 DiabetesBehavioural

    Also called BFST - Behavioral Family Systems Therapy

    BFST for Teens with Type 2 Diabetes: 12 (90 minute sessions) over 6 months of Behavioral Family Systems Therapy (BFST), delivered by a Licensed clinical social worker. BFST consists of 4 components: problem-solving, communication skills training, cognitive restructuring, and functional and structural family therapy.

Study groups in NCT03159221
Study groupRoleWhat they receive
BFST for Teens with Type 2 DiabetesExperimentalPsychological intervention: Families randomized to the intervention group will receive 12 sessions of Behavioral Family Systems Therapy for Teens with type 2 diabetes (BFST-DM2) over 6 months.
Receives: Behavioral: BFST for Teens with Type 2 Diabetes
Control group (Standard Care)No interventionThe participants assigned to the control group will receive their standard medical care for diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index (weight status) at 6 months and at 12 months

    Body Mass Index (adjusted for height, gender, and age) - height and weight in kg and meters (kg/m^2) - change in BMI across time points is being studied - change in weight from baseline to 6 months and change in weight from baseline to 12 months

    Measured: baseline, 6 months after baseline, 12 months after baseline

Secondary outcomes (10)
  1. metabolic control (HbA1c)

    Metabolic control is measured using HbA1c values

    Measured: baseline, 6 months after baseline, 12 months after baseline

  2. Treatment Adherence

    Treatment Adherence is measured using the Diabetes Self Management Survey for Teens with Type 2 Diabetes.

    Measured: baseline, 6 months after baseline, 12 months after baseline

  3. Family Problem-solving

    Family problem-solving is measured using the Revised Diabetes Family Conflict Scale

    Measured: baseline, 6 month after baseline

  4. Physical activity

    Physical activity is measured by an accelerometer

    Measured: baseline, 6 months after baseline

  5. Body Fat (weight status)

    Body fat percent change - measured by a hand-held body fat impedance device

    Measured: baseline, 6 months after baseline, 12 months after baseline

  6. Waist Circumference (weight status)

    Waist circumference in cm

    Measured: baseline, 6 months after baseline, 12 months after baseline

  7. Food intake

    Nutrition/food intake as measured by the Nutrition Data Systems for Research interview

    Measured: baseline, 6 months after baseline

  8. Family communication skills

    Family communication skills are measured by the Family Communication (Interaction Behavior Code)

    Measured: baseline, 6 months after baseline

  9. Teen Self-esteem

    Teen Self-Perception/Self-esteem is measured by the Harter Self-Perception Profile

    Measured: baseline, 6 months after baseline

  10. Teen Quality of Life

    Teen Quality of Life is measured by The Pediatric Quality of Life Inventory (PedsQL)

    Measured: baseline, 6 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2017
  2. Study startApr 2011
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03159221
Sponsor's protocol ID
Buckloh
Acronym
ADAPT
Status last verified
May 2017
First submitted
6 Oct 2015
Last updated
18 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BFST for Teens with Type 2 Diabetes in people with Diabetes Mellitus, Type 2 and Childhood Obesity, run by Nemours Children's Clinic 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 5 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 18 May 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.

What does the primary outcome measure?

Change in Body Mass Index (weight status) at 6 months and at 12 months (time frame: baseline, 6 months after baseline, 12 months after baseline). 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 18 May 2017.

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