N/A N=80 Supportive Care

SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women

Diabetes Mellitus in Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT03240874 ↗

Enrolled (actual)

Serious AEs

27.5%

Results posted

Mar 2023

Primary outcome: Primary: Number of Participants Identifying Themes on SweetMama Features — 9; 11; 11; 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SweetMama Focus Groups (Behavioral); SweetMama Individual Testing (Behavioral); SweetMama Feasibility Testing - Pilot Randomized Trial (Behavioral)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Northwestern University
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Identifying Themes on SweetMama Features	9; 11; 11; 2; 4; 3	—
PRIMARY Number of Participants Who Used the SweetMama Application	26; 9; 30; 0; 30; 0	—
SECONDARY Usage Time of SweetMama Application	20.5; 48.53	—
SECONDARY Usability Testing of SweetMama Application With the System Usability Scale Survey	75.00; 85.00	—
SECONDARY Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire	83.93; 82.14; 85.71; 88.31; 87.50; 91.07	—
SECONDARY Diabetes Self-efficacy	4.44; 3.88; 4.50; 4.50	—
SECONDARY Patient Activation	84.95; 88.31; 88.55; 93.85	—
SECONDARY Difference in Hemoglobin A1c From Enrollment to Delivery	3; 2; 10; 1; 16; 6	—

Summary

Diabetes during pregnancy is a challenging clinical situation requiring substantial patient engagement. The investigators have developed a novel early-phase tool, called SweetMama, that incorporates educational, motivational and supportive elements to positively impact maternal health behaviors. This phase of work involves develop an optimized version of SweetMama via a 2-step sequential process of in-depth usability and feasibility testing. First the investigators will conduct focus groups and individual usability testing followed by refinement of SweetMama based on participant input. Next, the investigators will conduct feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and pilot procedures for a fully powered larger trial.

Eligibility Criteria

Inclusion Criteria

Age 18 and older
Gestational diabetes mellitus or type 2 diabetes mellitus
English-speaking
Gestational age
Focus groups: Confirmed intrauterine pregnancy at least 8 weeks' gestational age or postpartum until 12 weeks after delivery
Individual testing: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
Pilot trial: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
Low income, defined as use of publicly-supported insurance for prenatal care or household income <200% of poverty line for family size
Access to a mobile smartphone ( for longitudinal testing phase)

Exclusion Criteria

Failure to meet the inclusion criteria above
Non-viable pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03240874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.