Evidence map›Paper›PMID 36343880›Full record

ArticleContemporary clinical trials2023

Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help family-based treatment program for children with overweight or obesity.

Kerri N Boutelle, Kyung E Rhee, Michael A Manzano, Rebecca S Bernard, David R Strong, Dawn M Eichen, Cheryl C A Anderson, Bess H Marcus, Natacha Akshoomoff, Scott J Crow

Open access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Kerri N BoutelleDepartment of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA; Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA. Electronic address: kboutelle@health.ucsd.edu.
Kyung E RheeDepartment of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Michael A ManzanoDepartment of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA; San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, 6363 Alvarado Court Suite 102, San Diego, CA 92120, USA.
Rebecca S BernardDepartment of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
David R StrongHerbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Dawn M EichenDepartment of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Cheryl C A AndersonHerbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Bess H MarcusDepartment of Behavioral and Social Sciences, Brown University, School of Public Health, 121 South Main Street, box G-S121-3, Providence, RI 02912-G, USA.
Natacha AkshoomoffDepartment of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA.
Scott J CrowDepartment of Psychiatry, University of Minnesota, F282/2A West 2450 Riverside Ave, Minneapolis, MN 55454, USA.
University of California, San Diego · USBrown University · USSan Diego State University · USUniversity of Minnesota · US

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
Effect of Treatment Dose on Childhood ObesityR01DK108686 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BOUTELLE, KERRI N · 2016 to 2020
$3.4M
NCATS NIH HHS UL1 TR001442NIDDK NIH HHS R01 DK108686
6 · The paper itself

Abstract

Overweight and obesity affect 45% of children and increases the risk for several negative health sequelae. Family-Based Behavioral Treatment (FBT) is the most efficacious treatment for child weight management and consists of nutrition and physical activity education, behavior change skills and parenting skills training. FBT is time and staff intensive and can include 20, 60-min separate groups for parents and children, as well as 20-min behavior coaching sessions to help problem solve barriers to implementing the skills learned and individualize the program. Guided self-help (GSH) therapies involve providing families a manual to review independently and brief coaching sessions by an interventionist to facilitate adherence. We developed a GSH version of FBT (gshFBT) which provides a manual to both parents and children and includes 14, 20-min coaching sessions over 6-months. The current study randomized 150 children (mean age = 10.1 years (SD = 1.38); mean BMI% = 97.3% (SD = 2.84); mean BMIz = 2.09 (SD = 0.40); 49% female; 43% Hispanic) and one of their parents (mean age = 41.8 years (SD = 6.52); mean BMI = 32.0 (SD = 7.24); 87.3% female; 43% Hispanic) to either a group-based FBT program or a gshFBT program. Assessments are conducted at baseline, post-treatment (6 months), 6-month follow-up (12 months) and 12-month follow-up (18 months). Primary outcomes are child weight change (BMIz) and cost effectiveness. Recruitment occurred between May 2017 and October 2021 and follow-up assessments are underway. Given the public health concern for children with obesity and the low level of access to FBT, gshFBT could prove extremely useful to provide intervention to a greater proportion of the population.

Indexed as

OverweightPediatric ObesityAdultChildEquivalence Trials as TopicExerciseFemaleHealth BehaviorHumansMaleParentsRandomized Controlled Trials as TopicChildFamily-based treatmentGuided self-helpLifestyle interventionWeight lossWeight management

Identifiers

PMID36343880
PMCPMC9968239
OpenAlexW4308499725

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.