NCT03550066

Brief Summary

This study examines whether a health message that includes a self-affirmation intervention (where people reflect on values that are important to them) increases acceptance of the message and encourages people to take steps to prevent diabetes, as compared to a health message without the self affirmation intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

May 14, 2018

Results QC Date

July 1, 2019

Last Update Submit

April 25, 2023

Conditions

Keywords

Diabetes, gestationalDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Acceptance of Health Message

    Index of message acceptance: Persuasiveness (rated on a 7-point scale from not at all (1) to very (7), with higher mean scores corresponding to greater persuasiveness)

    Up to 2 weeks

Secondary Outcomes (2)

  • Diabetes Prevention Behavior: Information Seeking

    Up to 2 weeks

  • Diabetes Prevention Behavior: Intention

    Up to 2 weeks

Study Arms (2)

Values affirmation

EXPERIMENTAL

In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values.

Behavioral: Values affirmation

No affirmation

ACTIVE COMPARATOR

In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation.

Behavioral: No affirmation

Interventions

A health message with a prompt asking participants to reflect on important personal values

Values affirmation
No affirmationBEHAVIORAL

A health message alone

No affirmation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of gestational diabetes
  • Body mass index ≥25 kg/m2
  • English or Spanish language

You may not qualify if:

  • Current diabetes
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Susan D. Brown
Organization
Kaiser Permanente Northern California

Study Officials

  • Susan D Brown, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 8, 2018

Study Start

June 1, 2018

Primary Completion

July 3, 2018

Study Completion

July 3, 2018

Last Updated

April 27, 2023

Results First Posted

August 20, 2019

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations