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NCT03834194: Bloom

Gestational Weight and Incentive Research Study

Completed NA Results posted Last updated 8 August 2023
What this trial tests

NA trial testing Lottery + Monthly Weight in Gestational Weight Gain in 40 participants. Completed in 9 April 2020.

Timeline
26 February 2019
Primary endpoint
9 April 2020
9 April 2020

Quick facts

Lead sponsorUniversity of Tennessee
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingnone
Primary purposesupportive care
Enrollment40
Start date26 February 2019
Primary completion9 April 2020
Estimated completion9 April 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Tennessee

Who can join

18 and older, female only, with Gestational Weight Gain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Satisfaction Observed From Follow-up Survey Primary · Up to 32 weeks

At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive).

How much would you recommend using an e-scale for managing GWG to a friend?
GroupValue95% CI
Lottery + Monthly Weight55 – 5
Lottery + Overall Weight + Exercise4.253 – 5
Lottery + Overall Weight4.252 – 5
Lottery + Monthly Weight + Exercise55 – 5
Loss + Monthly Weight4.84 – 5
Loss + Overall Weight + Exercise4.754 – 5
Loss + Overall Weight4.84 – 5
Loss + Monthly Weight + Exercise4.84 – 5
How much would you recommend using a fitness tracker for managing GWG to a friend?
GroupValue95% CI
Lottery + Monthly Weight4.674 – 5
Lottery + Overall Weight + Exercise3.52 – 5
Lottery + Overall Weight55 – 5
Lottery + Monthly Weight + Exercise55 – 5
Loss + Monthly Weight4.42 – 5
Loss + Overall Weight + Exercise4.253 – 5
Loss + Overall Weight4.64 – 5
Loss + Monthly Weight + Exercise4.43 – 5
How much would you recommend setting a weight gain goal for managing GWG to a friend?
GroupValue95% CI
Lottery + Monthly Weight4.674 – 5
Lottery + Overall Weight + Exercise4.253 – 5
Lottery + Overall Weight4.53 – 5
Lottery + Monthly Weight + Exercise55 – 5
Loss + Monthly Weight4.43 – 5
Loss + Overall Weight + Exercise4.754 – 5
Loss + Overall Weight4.84 – 5
Loss + Monthly Weight + Exercise4.64 – 5
How much would you recommend setting a physical activity goal for managing GWG to a friend?
GroupValue95% CI
Lottery + Monthly Weight43 – 5
Lottery + Overall Weight + Exercise4.253 – 5
Lottery + Overall Weight4.53 – 5
Lottery + Monthly Weight + Exercise55 – 5
Loss + Monthly Weight55 – 5
Loss + Overall Weight + Exercise4.253 – 5
Loss + Overall Weight4.84 – 5
Loss + Monthly Weight + Exercise4.84 – 5
Recruitment Yields Observed From Enrollment Survey Primary · Up to 36 weeks

The number of participants initially recruited for the study will be closely monitored.

GroupValue95% CI
Lottery + Monthly Weight4
Lottery + Overall Weight + Exercise5
Lottery + Overall Weight5
Lottery + Monthly Weight + Exercise5
Loss + Monthly Weight5
Loss + Overall Weight + Exercise5
Loss + Overall Weight5
Loss + Monthly Weight + Exercise5
Program Retention Observed From Enrollment and Followup Surveys Primary · Up to 36 weeks

The number of participants stayed in the study within the time frame of the study will be closely monitored.

GroupValue95% CI
Lottery + Monthly Weight3
Lottery + Overall Weight + Exercise4
Lottery + Overall Weight4
Lottery + Monthly Weight + Exercise5
Loss + Monthly Weight5
Loss + Overall Weight + Exercise4
Loss + Overall Weight5
Loss + Monthly Weight + Exercise5
Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks Secondary · Up to 36 weeks

At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to

GroupValue95% CI
Lottery + Monthly Weight13.210.0 – 18.0
Lottery + Overall Weight + Exercise6.80.9 – 11.2
Lottery + Overall Weight8.4-3.7 – 14.2
Lottery + Monthly Weight + Exercise9.48.1 – 11.2
Loss + Monthly Weight9.6-2.1 – 20.1
Loss + Overall Weight + Exercise8.9-0.2 – 13.3
Loss + Overall Weight11.83.4 – 18.8
Loss + Monthly Weight + Exercise11.86.9 – 15.0
Number of Participants With Gestational Weight Gain Within IOM Recommendation Secondary · Up to 36 weeks pregnancy

We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain.

GroupValue95% CI
Lottery + Monthly Weight2
Lottery + Overall Weight + Exercise2
Lottery + Overall Weight0
Lottery + Monthly Weight + Exercise1
Loss + Monthly Weight2
Loss + Overall Weight + Exercise2
Loss + Overall Weight1
Loss + Monthly Weight + Exercise3

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to 36 weeks gestation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lottery + Monthly Weight
Serious: 1/4 (25%)
Deaths: 0/4
Lottery + Overall Weight + Exercise
Serious: 0/5 (0%)
Deaths: 0/5
Lottery + Overall Weight
Serious: 1/5 (20%)
Deaths: 0/5
Lottery + Monthly Weight + Exercise
Serious: 1/5 (20%)
Deaths: 0/5
Loss + Monthly Weight
Serious: 0/5 (0%)
Deaths: 0/5
Loss + Overall Weight + Exercise
Serious: 0/5 (0%)
Deaths: 0/5
Loss + Overall Weight
Serious: 0/5 (0%)
Deaths: 0/5
Loss + Monthly Weight + Exercise
Serious: 0/5 (0%)
Deaths: 0/5

Serious adverse events (2 terms)

ReactionSystemLottery + Monthly WeightLottery + Overall Weight +…Lottery + Overall WeightLottery + Monthly Weight +…Loss + Monthly WeightLoss + Overall Weight + Ex…Loss + Overall WeightLoss + Monthly Weight + Ex…
Premature birthPregnancy, puerperium and perinatal conditions
MiscarriagePregnancy, puerperium and perinatal conditions

Most-reported serious reactions: Premature birth, Miscarriage.

Data from ClinicalTrials.gov NCT03834194 adverse events section.

Sponsor's own description

Bloom is a research study that examines whether incentives for daily self-weighing, weekly physical activity, monthly weight management or overall (from enrollment up to 36 weeks pregnancy) weight management could help pregnant mothers manage a health weight gain during pregnancy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Pragmatic Intervention Using Financial Incentives for Pregnancy Weight Management: Feasibility Randomized Controlled Trial.
    Krukowski R, Johnson B, Kim H, Sen S, et al · · 2021 · cited 3× · PMID 34951594 · DOI 10.2196/30578

Verify or expand the search:

Other recruiting trials for Gestational Weight Gain

Currently open trials in the same condition.

Other University of Tennessee trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03834194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing