Familial Overweight: Comparing Use of Strategies

NCT00746629 | Completed

• 2 other identifiers: HD54871 (completed)1R21DK095676
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of two different approaches (prescribed \& self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Child weight status, physical activity, & diet.

  6 Months

Secondary Outcomes (1)

• Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.

  6 Months

Study Arms (2)

Prescribed Skills

ACTIVE COMPARATOR

Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment

Behavioral: FOCUS

Self-Directed Skills

EXPERIMENTAL

Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.

Behavioral: FOCUS

Interventions

FOCUS BEHAVIORAL

Treatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed". Children and parents will be weighed at each clinic visit.

Prescribed Skills; Self-Directed Skills

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child age: 7-11 years.
• English-speaking.
• Parent is willing and able to actively participate in treatment.
• Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
• Overweight parent: BMI≥ 25.
• Live within 50 miles of Children's Hospital and Regional Medical Center.

You may not qualify if:

• Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
• Already involved with another weight control program.
• Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
• Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
• Taking weight-affecting medications (e.g. Ritalin)
• Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
• Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
• Participating parent or child: Current or prior diagnosed eating disturbance.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Seattle Children's Hospital Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Saelens BE, Lozano P, Scholz K. A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. J Pediatr Psychol. 2013 Oct;38(9):954-64. doi: 10.1093/jpepsy/jst054. Epub 2013 Jul 31.

  PMID: 23902797 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian E Saelens, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

US (1)