MOD Diet in Gestational Diabetes Mellitus

NCT04570111 | Terminated

• 1 other identifier: 145905
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational diabetes (GDM) is a condition of high blood glucose (or "blood sugar") during pregnancy. GDM can cause harmful short-term and long-term health effects for mom and baby. Diet therapy is an effective way to achieve normal blood glucose for women with GDM, but the best diet is unknown. Diet strategies that improve blood glucose in GDM and that patients can follow are needed for better clinical care. In studies of non-pregnant individuals with diabetes, eating a high fat/protein breakfast as the only dietary change was enough to improve glucose control. Because highest blood glucose readings in GDM usually occur after breakfast, a high fat/protein breakfast could also improve glucose control in GDM. In this study, two dietary strategies for improving blood glucose will be compared. Ten women newly diagnosed with GDM (\<30 weeks in pregnancy) will be enrolled in a 12-day cross-over controlled feeding study with a high fat/protein breakfast, which is named a 'Macro-Optimized Diet' (MOD) or standard care diet (SC). In other words, subjects will have all food provided to them, and they will consume each diet for a few days while researchers monitor their blood glucose. Most nutrition aspects of the two diets will be similar, but the MOD diet will vary the timing of eating carbohydrate, protein, and fat to achieve fewer carbs at breakfast. After the 12-day controlled feeding period, participants will continue one of the study diets (as randomized) until delivery. During this time, research team dietitians will provide personalized nutrition education to support GDM self-management. The study will evaluate whether the diet is acceptable to women with GDM and their clinic providers. Data to be collected include blood glucose data, patient and provider feedback on diet acceptability, weight gain, the number of participants who are prescribed blood glucose control medications, and infant weight. These data will be used to evaluate trends pointing to whether one diet is more effective.

Conditions

Gestational Diabetes

Keywords

diet therapy; patient education

Outcome Measures

Primary Outcomes (2)

• Diet Satisfaction

  Diet satisfaction will be measured by the Diet Satisfaction Questionnaire (James et al, 2018), a 28-item validated survey that measures diet satisfaction on 7 scales (healthy lifestyle, convenience, cost, family dynamics, preoccupation with food, negative aspects, and planning and preparation). Item statements are rated by participants on a 5-point Likert scale. Acceptability of both diets will be evaluated by degree of agreement with survey items using means +/- standard deviations for 7 subscales of diet satisfaction.

  18 months

• Adherence to the study diet

  Adherence to the study diet will be measured during both phases of the study. During the controlled feeding portion of the study, participants will log their % consumption of all meals and snacks and return logs to the research team. For the self-monitored phase, three multiple pass 24 hour dietary recalls will be collected by trained staff. Macronutrient analysis of 24 hour recalls will be evaluated by eating occasion to determine diet adherence. Participants will also keep daily logs for food intake at breakfast. Logs will be sent weekly to the study team electronically. Adherence will be calculated as number of days meeting macronutrient goals at breakfast for both 24 hr recalls and logs. Participants will be considered adherent if meeting goal at least 75% of the time.

  18 months

Secondary Outcomes (4)

• Glucose Incremental area under the curve (iAUC)

  12 months

• Prescription rates

  18 months

• Gestational weight gain

  18 months

• Infant weight

  18 months

Study Arms (2)

Standard Care Diet

ACTIVE COMPARATOR

After the controlled feeding study, participants in this group will follow the standard care diet for the remainder of pregnancy with the assistance of a study dietitian. The standard care study diet will provide the standard 40% Carb/20% Pro/40% Fat as energy, distributed consistently across 3 meals and 2 snacks.

Other: Standard Care Diet

Macro-Optimized Diet (MOD)

EXPERIMENTAL

After the controlled feeding study, participants in this group will follow the MOD diet for the remainder of pregnancy with the assistance of a study dietitian. The MOD diet will differ from control by macronutrient distribution at breakfast specifically, but also at each eating occasion, although the daily macronutrient distribution is equal to the control diet. At breakfast, the MOD diet will provide 10% Carb/30% Pro/60% Fat.

Other: MOD Diet

Interventions

MOD Diet OTHER

The macro-optimized diet alters the timing of macronutrient intake to provide fewer carbohydrates at breakfast, while maintaining recommended amounts of macronutrients delivered throughout the course of the day

Macro-Optimized Diet (MOD)

Standard Care Diet OTHER

The standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day.

Standard Care Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between the ages 18-40 years old
• A positive GDM diagnosis at 24-28 weeks gestation
• GDM management by diet alone
• willing to consume food provided in the study
• English speaking

You may not qualify if:

• multiple gestation
• hypertriglyceridemia (fasting TG \>400 mg/dL)
• suspected overt diabetes (previous A1c≥6.5)
• smoker
• fasting glucose \>110mg/dL
• overt cognitive impairment
• presence of risk factors for placental insufficiency or growth restriction (e.g.
• hypertension, renal disease, history of preeclampsia, use of β-blockers)
• history of preterm birth
• other major medical disorder

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Heather D Gibbs, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 30, 2020
• Study Start: January 22, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)