Evidence map›Paper›PMID 28867396›Full record

ArticleContemporary clinical trials2018

The Healthy Hearts and Kidneys (HHK) study: Design of a 2×2 RCT of technology-supported self-monitoring and social cognitive theory-based counseling to engage overweight people with diabetes and chronic kidney disease in multiple lifestyle changes.

Mary Ann Sevick, Kathleen Woolf, Aditya Mattoo, Stuart D Katz, Huilin Li, David E St-Jules, Ram Jagannathan, Lu Hu, Mary Lou Pompeii, Lisa Ganguzza and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02276742 (Lifestyle Management of CKD in Obese Diabetic Patients), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 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.

NCT02276742 nacompletednot on this map

Lifestyle Management of CKD in Obese Diabetic Patients

TypeinterventionalSponsorNYU Langone HealthRan2014 to 2019Enrolled269ConditionsObesity, Type 2 Diabetes, Chronic Kidney Disease (CKD)ArmsSocial Cognitive Theory, Monitoring
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Education programmes for people with chronic kidney disease and diabetes.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Altered dietary salt intake for people with chronic kidney disease.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Pooled it
  5. An Evaluation of Alternative Technology-Supported Counseling Approaches to Promote Multiple Lifestyle Behavior Changes in Patients With Type 2 Diabetes and Chronic Kidney Disease.Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation · 2023
    Trial
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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

14 authors.

Mary Ann SevickNew York University School of Medicine, Center for Healthful Behavior Change, United States. Electronic address: mary.sevick@nyumc.org.
Kathleen WoolfNew York University Steinhardt, Department of Nutrition, Food Studies and Food Studies, United States.
Aditya MattooNew York University Medical Center, Division of Nephrology, United States.
Stuart D KatzNew York University Medical Center, Division of Cardiology, United States.
Huilin LiNew York University School of Medicine, Division of Biostatistics, United States.
David E St-JulesNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Ram JagannathanNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Lu HuNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Mary Lou PompeiiNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Lisa GanguzzaNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Zhi LiNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Alex SierraNew York University School of Medicine, Center for Healthful Behavior Change, United States.
Stephen K WilliamsNew York University School of Medicine, Center for Healthful Behavior Change, United States.
David S GoldfarbNew York University Medical Center, Division of Nephrology, United States.

Funding

Lifestyle Management of CKD in Obese Diabetic PatientsR01DK100492 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI SEVICK, MARY A · 2014 to 2018
$3.6M
Program to Improve Care in Complex Chronic DiseaseK24NR012226 · NINR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SEVICK, MARY A · 2011 to 2015
$602k
NIDDK NIH HHS R01 DK100492NINR NIH HHS K24 NR012226
6 · The paper itself

Abstract

Patients with complex chronic diseases usually must make multiple lifestyle changes to limit and manage their conditions. Numerous studies have shown that education alone is insufficient for engaging people in lifestyle behavior change, and that theory-based behavioral approaches also are necessary. However, even the most motivated individual may have difficulty with making lifestyle changes because of the information complexity associated with multiple behavior changes. The goal of the current Healthy Hearts and Kidneys study was to evaluate, different mobile health (mHealth)-delivered intervention approaches for engaging individuals with type 2 diabetes (T2D) and concurrent chronic kidney disease (CKD) in behavior changes. Participants were randomized to 1 of 4 groups, receiving: (1) a behavioral counseling, (2) technology-based self-monitoring to reduce information complexity, (3) combined behavioral counseling and technology-based self-monitoring, or (4) baseline advice. We will determine the impact of randomization assignment on weight loss success and 24-hour urinary excretion of sodium and phosphorus. With this report we describe the study design, methods, and approaches used to assure information security for this ongoing clinical trial. Clinical Trials.gov Identifier: NCT02276742.

Indexed as

Health BehaviorAdultAgedBehavior TherapyBlood PressureBody CompositionComputers, HandheldDiabetes Mellitus, Type 2DietExerciseFemaleHumansLife StyleLipidsLongitudinal StudiesMaleLipidsPenicillin GPhosphorus, DietarySodium, DietaryBehaviorClinical trialDiabetes mellitus, type 2Diabetic nephropathyExercisemHealth, weight lossPhosphorus, dietarySodium, dietary

Identifiers

PMID28867396
PMCPMC6007843

What OpenQuestion holds

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Registered trials

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.