Evidence map›Paper›PMID 27978848›Full record

Trial reportTrials2016

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children.

Siobhan Creanor, Jenny Lloyd, Melvyn Hillsdon, Sarah Dean, Colin Green, Rod S Taylor, Emma Ryan, Katrina Wyatt, HeLP Trial Management Group

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

8 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Interventions to prevent obesity in children aged 5 to 11 years old.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Interventions for preventing obesity in children.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Human vaccines & immunotherapeutics · 2022
    Trial
  6. Trial
  7. Trial
  8. Article
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

9 authors.

Siobhan CreanorPeninsula Clinical Trials Unit and Medical Statistics Group, Plymouth University Peninsula Schools of Medicine and Dentistry (formerly Peninsula College of Medicine and Dentistry), ITTC Building, Plymouth Science Park, Plymouth, Devon, PL6 8BX, UK. siobhan.creanor@plymouth.ac.uk.ORCID 0000-0002-7373-8263
Jenny LloydInstitute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), South Cloisters, St. Luke's Campus, Exeter, Devon, EX1 2LU, UK.
Melvyn HillsdonSport and Health Sciences, College of Life and Environmental Sciences, University of Exeter St. Luke's Campus, Heavitree Road, Exeter, Devon, EX1 2LU, UK.
Sarah DeanInstitute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), South Cloisters, St. Luke's Campus, Exeter, Devon, EX1 2LU, UK.
Colin GreenInstitute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), South Cloisters, St. Luke's Campus, Exeter, Devon, EX1 2LU, UK.
Rod S TaylorInstitute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), South Cloisters, St. Luke's Campus, Exeter, Devon, EX1 2LU, UK.
Emma RyanIsca Academy, Earl Richards Road, Exeter, Devon, EX2 6AP, UK.
Katrina WyattInstitute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), South Cloisters, St. Luke's Campus, Exeter, Devon, EX1 2LU, UK.
HeLP Trial Management Group

Funding

Department of Health 10/3010/01
6 · The paper itself

Abstract

backgroundThe Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. METHODS AND

designThe HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses.

trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012.

Indexed as

Data Interpretation, StatisticalHealthy LifestyleRisk Reduction BehaviorAge FactorsChildChild BehaviorCluster AnalysisEnglandFemaleHealth BehaviorHealth Knowledge, Attitudes, PracticeHealth PromotionHumansMalePediatric ObesityPreventive Health ServicesChildhood obesityCluster randomised controlled trialSchool-basedStatistical analysis plan

Identifiers

PMID27978848
PMCPMC5159986

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.