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Completed

NCT Number: NCT03811743

A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)

The purpose of this research is to develop a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

Participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. These sessions will work to facilitate an increase in self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs. Joint goal setting and tracking will be enabled by commercially available devices and apps. Each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the Brenner FIT team to monitor and encourage. Furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families.

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 By Design is an adult (>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for enrollment in Brenner FIT and/or By Design Essentials
  • Caregiver who lives in the house with a BMI > 30
  • No contraindication for physical activity or caloric restriction
  • Must be able to read and write English

Exclusion criteria

  • Over the age of 65
  • BMI < 30
  • Contraindication for physical activity or caloric restriction
  • Cannot read or write English

Treatment and study plan

Brenner FIT

Behavioral

Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.

By Design

Behavioral

Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.

Coordination

Behavioral

This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.

Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment

Primary outcomes

  1. BMI z-score

    Time frame: Baseline

    Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

  2. BMI z-score

    Time frame: 3 Months

    Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

  3. BMI z-score

    Time frame: 6 months

    Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

Secondary outcomes

  1. Physical Activity Assessed by Accelerometry

    Time frame: Baseline

    Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.

  2. Physical Activity Assessed by Accelerometry

    Time frame: 6 months

    Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.

  3. Physical Activity Assessed by PAQ-A

    Time frame: Baseline

    The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.

    The PAQ-A ranges from 1-7. Higher score denotes better outcome.

  4. Physical Activity Assessed by PAQ-A

    Time frame: 6 months

    The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.

    The PAQ-A ranges from 1-7. Higher score denotes better outcome.

  5. Physical Activity Assessed by IPAQ

    Time frame: Baseline

    The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.

    The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.

  6. Physical Activity Assessed by IPAQ

    Time frame: 6 months

    The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.

    The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.

  7. Caloric intake expressed in kcals

    Time frame: Baseline

    Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.

  8. Caloric intake expressed in kcals

    Time frame: 6 months

    Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.

  9. Concentration of fasting glucose for all participants, mg/dL

    Time frame: Baseline

    Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.

  10. Concentration of fasting glucose for all participants, mg/dL

    Time frame: 6 months

    Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.

  11. Concentration of fasting Insulin for all participants, mg/dL

    Time frame: Baseline

    Fasting insulin levels will be gathered from all participants.

  12. Concentration of fasting Insulin for all participants, mg/dL

    Time frame: 6 months

    Fasting insulin levels will be gathered from all participants.

  13. Hemoglobin A1c concentration for all participants, measured in percentage

    Time frame: Baseline

    Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.

  14. Hemoglobin A1c concentration for all participants, measured in percentage

    Time frame: 6 months

    Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.

  15. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)

    Time frame: Baseline

    AST a useful test for detecting or monitoring liver damage.

  16. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)

    Time frame: 6 months

    AST a useful test for detecting or monitoring liver damage.

  17. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter

    Time frame: Baseline

    A low level of ALT in the blood is expected and is normal.

  18. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter

    Time frame: 6 months

    A low level of ALT in the blood is expected and is normal.

  19. Concentration of total cholesterol (mg/dL)

    Time frame: Baseline

    total cholesterol: less than 200 mg/dL

  20. Concentration of total cholesterol (mg/dL)

    Time frame: 6 months

    total cholesterol: less than 200 mg/dL

  21. Economic costs of the three intervention arms over duration of program (USD)

    Time frame: Baseline through 6 months

    Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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