Evidence map›Paper›PMID 40834924›Full record

ArticleContemporary clinical trials2025

The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics.

Cynthia L Stowe, Kimberly Kennedy, Shannon S Emilson, Rebecca H Neiberg, Stephen B Kritchevsky, Michael E Miller, Denise K Houston, Barbara J Nicklas, Jason Fanning, W Jack Rejeski and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05424042 (Health, Aging and Later-Life Outcomes Pilot Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT05424042 nacompletednot on this map

Health, Aging and Later-Life Outcomes Pilot Trial (HALLO-P): A 9-month Randomized Pilot Trial of 3 Nutritional Interventions in 120 Older Adults With an Indication for Weight Loss

TypeinterventionalSponsorWake Forest University Health SciencesRan2022 to 2024Enrolled90ConditionsAgingArmsIn-Person Caloric Restriction, Remote Caloric Restriction, Time-restricted
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

11 authors.

Cynthia L StoweWake Forest University School of Medicine, Winston-Salem, NC, United States. Electronic address: cstowe@wakehealth.edu.
Kimberly KennedyWake Forest University School of Medicine, Winston-Salem, NC, United States.
Shannon S EmilsonWake Forest University School of Medicine, Winston-Salem, NC, United States.
Rebecca H NeibergWake Forest University School of Medicine, Winston-Salem, NC, United States.
Stephen B KritchevskyWake Forest University School of Medicine, Winston-Salem, NC, United States.
Michael E MillerWake Forest University School of Medicine, Winston-Salem, NC, United States.
Denise K HoustonWake Forest University School of Medicine, Winston-Salem, NC, United States.
Barbara J NicklasWake Forest University School of Medicine, Winston-Salem, NC, United States.
Jason FanningWake Forest University, Winston-Salem, NC, United States.
W Jack RejeskiWake Forest University, Winston-Salem, NC, United States.
HALLO-P Investigators

Funding

Wake Forest Claude D. Pepper OAIC - RenewalP30AG021332 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Jamie Nicole Justice · 2002 to 2026
$36.4M
Wake Forest Clinical and Translational Science AwardUL1TR001420 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, FOLEY, KRISTIE L · 2015 to 2023
$32.3M
The Mobile Devices for Meal Timing (MD4MT) Study: A supplement to HALLO-P using multiple wearable devise to improve accuracy in meal timing for older adults2U01AG073240 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KRITCHEVSKY, STEPHEN B., MILLER, MICHAEL E. · 2021 to 2024
$4.4M
NCATS NIH HHS UL1 TR001420NIA NIH HHS P30 AG021332NIA NIH HHS U01 AG073240
6 · The paper itself

Abstract

backgroundMulti-morbidity increases significantly with age, and obesity is a major risk factor for conditions like cardiovascular disease and diabetes, indicating a critical need for effective interventions.

objectiveWe discuss the study design of the HALLO-Pilot Study that randomized older adults to in-person caloric restriction (CR), remotely delivered CR (RCR), or a time restricted eating (TRE) intervention. In addition, we emphasize inclusion/exclusion criteria, recruitment, and baseline characteristics of randomized participants.

methodsThe study randomized 90 participants aged 60+ to one of three 9-month interventions. Eligibility focused on including adults with an indication for weight loss while excluding for safety concerns or factors potentially affecting adherence. Screening involved telephone interviews and in-person visits. Assessments included measures for eligibility, outcomes, adherence, and safety, with data collected at baseline, 6 months, and 9 months. The intervention involved in-person or online group meetings and individual contacts with participants monthly. Interventions included nutritional and behavioral guidance and a targeted increase in steps per day. Remote monitoring technology was used for monitoring diet and weight for CR participants and logging eating times for TRE participants.

resultsThere were a total of 1753 pre-screening contacts with 678 (39 %) completing telephone screening. Of 139 (∼21 %) who were eligible after the telephone screening and consented, 135 participants attended in-person screening visits. Of those screened in-person, 90 were eligible and randomized for a yield of 13 %.

conclusionThe HALLO-Pilot Study provided valuable insights into eligibility criteria and the recruitment of older adults for future large-scale trials of CR and TRE. CLINICAL TRIALS: gov: NCT05424042.

Indexed as

Caloric RestrictionObesityPatient SelectionAgedAged, 80 and overFemaleHumansMaleMiddle AgedPilot ProjectsRandomized Controlled Trials as TopicResearch DesignWeight LossCaloric-restrictionOlder adultsRemote monitoringTeleconferencing interventionTime-restricted eatingTrial design

Identifiers

PMID40834924
PMCPMC12435094

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.