Extension Family Lifestyle Intervention Project (E-FLIP for Kids)

NCT01820338 | Completed DMC

• 1 other identifier: 204-2009
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate the impact of a community based intervention delivered to families in rural settings utilizing the existing Cooperative Extension Service network on child dietary intake and weight. Specifically, the E-FLIP for Kids study will determine if behavioral treatments for child obesity lead to greater improvement in child weight compared to educational only treatment.Participants will include 240 parent-child dyads from ten rural counties in north central Florida. Study outcomes will be measure prior to treatment, at the end of treatment (month 12) and at one year follow-up (month 24). All treatment meetings will be held at Cooperative Extension Service offices within each participating county.

Conditions

Obesity

Keywords

Children, Obesity, Intervention

Outcome Measures

Primary Outcomes (1)

• Child BMI Z score

  Change in Child BMI Z score from baseline to year 2

  2 years

Secondary Outcomes (2)

• Child caloric intake

  2 years

• Child Physical Activity

  2 years

Study Arms (3)

Behavioral Family Intervention

EXPERIMENTAL

Child and Parent attend intervention including nutrition and physical activity education, plus behavioral strategies to facilitate behavior and weight status change

Behavioral: Behavioral Child Tx Contacts; Behavioral: Behavioral Parent-Tx Contacts; Other: Dietary and Physical Activity Information

Behavioral Parent-Only Intervention

EXPERIMENTAL

Only parents attend intervention including nutrition and physical activity education, plus behavioral strategies to facilitate behavior and weight status change

Behavioral: Behavioral Parent-Tx Contacts; Other: Dietary and Physical Activity Information

Education Control

ACTIVE COMPARATOR

Child and parent attend intervention that includes only nutrition and physical activity education; no instruction or assistance in the use of behavioral strategies are included in this condition

Other: Dietary and Physical Activity Information

Interventions

Behavioral Child Tx Contacts BEHAVIORAL

Each parent and child dyad will participate in group meetings. Children and parents will meet in simultaneous, but separate, groups at each meeting. The intervention will include 12 sessions over 16 weeks. Families will also participate in a maintenance intervention for the next eight months. The primary treatment objectives will be to decrease caloric intake in a nutritionally sound manner and to increase moderate intensity exercise. Changes in dietary habits will be addressed via a modified version of the Stoplight System. Children and adults will be encouraged to eat a well-balanced diet based on the food guide pyramid. Parents and children will also be given pedometers and they will be asked to keep track of the number of steps they take each day. Each week parents and children will set goals to gradually increase physical activity. Parent and their children will be asked to record what they eat and drink, as well as their physical activity on daily food logs.

Behavioral Family Intervention

Behavioral Parent-Tx Contacts BEHAVIORAL

Only the participating parent(s) will attend group meetings. The intervention will include weekly sessions for the first 8 weeks and biweekly sessions for the next 8 weeks. They will also participate in a maintenance intervention for eight months. Each session will last 90 minutes. The sessions for parents in the parent-only program will be structured the same as the parents sessions for the family-based intervention and will also cover the same topics. As with the family-based intervention, the parent and their children assigned to the parent-only intervention will be asked to record what they eat and drink, as well as their physical activity, on a daily basis. Each week group interventionists will model the goal setting process with parents and suggest a general range of age-appropriate dietary and physical activity targets that might be appropriate for each child and parent.

Behavioral Family Intervention; Behavioral Parent-Only Intervention

Dietary and Physical Activity Information OTHER

Both the child and parent will attend the treatment sessions in this program. The condition will include a series of meetings addressing key aspects of nutrition, physical activity, and health promotion such as national guidelines regarding proper nutrition, guidelines for physical activity, strategies to cope with stress, healthy sources and guidelines for intake of fiber, calcium, protein, grains \& carbohydrates. Topics will also include use of vitamin \& mineral supplements, dental and sleep hygiene, self-esteem, family communication, and assertiveness training in dealing with peer victimization. The families in the Health Education group will not receive training in behavioral self-regulation strategies, such as goal setting and self-monitoring. Children will participate in a group physical activity during each session such as frisbee, jump rope, stoplight tag. They will also sample healthy snacks such as pretzels or fruits and vegetables.

Behavioral Family Intervention; Behavioral Parent-Only Intervention; Education Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 8 and 12 years,
• BMI equal to or above the 85th percentile for age and gender
• Child and participating parent(s) or legal guardian(s) are required to live within the same dwelling in a rural county.
• Participating parents or legal guardians must be age 75 years or less.

You may not qualify if:

• Child or participating parent has a dietary or exercise restriction
• Medical condition that contraindicates mild energy restriction or moderate physical activity
• Children or adults cannot be engaged in another weight control program.
• Unwilling or unable to give informed consent,
• Parent(s) or legal guardian(s) unable to read English at approximately the 5th grade level,
• Unwilling to accept random assignment,
• Unable to travel to the Extension office for intervention sessions,
• Likely to move out of the county within the next 24 months.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (8)

• Janicke DM, Lim CS, Perri MG, Bobroff LB, Mathews AE, Brumback BA, Dumont-Driscoll M, Silverstein JH. The Extension Family Lifestyle Intervention Project (E-FLIP for Kids): design and methods. Contemp Clin Trials. 2011 Jan;32(1):50-8. doi: 10.1016/j.cct.2010.08.002. Epub 2010 Aug 11.

  PMID: 20708715 BACKGROUND

• Lim CS, Mayer-Brown SJ, Clifford LM, Janicke DM. Pain is Associated with Physical Activity and Health-Related Quality of Life in Overweight and Obese Children. Child Health Care. 2014 Jul;43(3):186-202. doi: 10.1080/02739615.2013.837825.

  PMID: 25484483 BACKGROUND

• Lim, C.S. & Janicke, D.M. (2013). Barriers related to delivering pediatric weight management interventions to children and families from rural communities. Children's Health Care, 42, 214-230.

  BACKGROUND

• Gowey MA, Lim CS, Clifford LM, Janicke DM. Disordered eating and health-related quality of life in overweight and obese children. J Pediatr Psychol. 2014 Jun;39(5):552-61. doi: 10.1093/jpepsy/jsu012. Epub 2014 Mar 26.

  PMID: 24676798 RESULT

• Fedele DA, Janicke DM, Lim CS, Abu-Hasan M. An examination of comorbid asthma and obesity: assessing differences in physical activity, sleep duration, health-related quality of life and parental distress. J Asthma. 2014 Apr;51(3):275-81. doi: 10.3109/02770903.2013.873807. Epub 2014 Jan 10.

  PMID: 24320738 RESULT

• Labyak CA, Janicke DM, Lim CS, Colee J, Mathews AE. Anthropometrics to Identify Overweight Children at Most Risk for the Development of Cardiometabolic Disease. Infant Child Adolesc Nutr. 2013 Dec;5(6):341-346. doi: 10.1177/1941406413501379.

  PMID: 25485038 RESULT

• Janicke DM, Lim CS, Perri MG, Mathews AE, Bobroff LB, Gurka MJ, Parish A, Brumback BA, Dumont-Driscoll M, Silverstein JH. Featured Article: Behavior Interventions Addressing Obesity in Rural Settings: The E-FLIP for Kids Trial. J Pediatr Psychol. 2019 Sep 1;44(8):889-901. doi: 10.1093/jpepsy/jsz029.

  PMID: 31039250 DERIVED

• Graef DM, Janicke DM, McCrae CS. Sleep patterns of a primarily obese sample of treatment-seeking children. J Clin Sleep Med. 2014 Oct 15;10(10):1111-7. doi: 10.5664/jcsm.4112.

  PMID: 25317092 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David M Janicke, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 28, 2013
• Study Start: July 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

US (1)