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Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

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ClinicalTrials.gov Identifier: NCT01631747
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Linda Van Horn, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pregnancy
Weight Gain
Interventions: Behavioral: Lifestyle Intervention Group
Behavioral: Usual Care Group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women were screened from multiple practices at the Prentice Women’s Hospital of Northwestern Memorial Hospital. Screening took place between Feb 2013-Dec 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women completed baseline clinic visit and two 24 hour recalls prior to randomization.

Reporting Groups
  Description
Usual Care Group

Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.

Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.

Lifestyle Intervention Group

Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer

Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer


Participant Flow for 3 periods

Period 1:   Randomization Through End of Pregnancy
    Usual Care Group   Lifestyle Intervention Group
STARTED   141   140 
COMPLETED   140   140 
NOT COMPLETED   1   0 
Lost to Follow-up                1                0 

Period 2:   Live Birth
    Usual Care Group   Lifestyle Intervention Group
STARTED   140   140 
COMPLETED   136   139 
NOT COMPLETED   4   1 
Pregnancy Termination                1                0 
MIscarriage                2                0 
Stillbirth                1                1 

Period 3:   One Year Infant Outcomes
    Usual Care Group   Lifestyle Intervention Group
STARTED   136   139 
COMPLETED   123   130 
NOT COMPLETED   13   9 
Patient Refused                13                9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care Group

Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.

Usual Care Group: Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.

Lifestyle Intervention Group

Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer

Lifestyle Intervention Group: Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer

Total Total of all reporting groups

Baseline Measures
   Usual Care Group   Lifestyle Intervention Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   140   281 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (4)   33  (4)   33  (4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      141 100.0%      140 100.0%      281 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      30  21.3%      30  21.4%      60  21.4% 
Not Hispanic or Latino      111  78.7%      110  78.6%      221  78.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   1.4%      0   0.0%      2   0.7% 
Asian      4   2.8%      6   4.3%      10   3.6% 
Native Hawaiian or Other Pacific Islander      1   0.7%      0   0.0%      1   0.4% 
Black or African American      20  14.2%      34  24.3%      54  19.2% 
White      99  70.2%      79  56.4%      178  63.3% 
More than one race      5   3.5%      9   6.4%      14   5.0% 
Unknown or Not Reported      10   7.1%      12   8.6%      22   7.8% 
Region of Enrollment 
[Units: Participants]
     
United States   141   140   281 
Gestational Age at Randomization 
[Units: Weeks]
Mean (Standard Deviation)
 13  (1)   13  (1)   13  (1) 
Pre-pregnancy BMI 
[Units: Kg per meters-squared]
Mean (Standard Deviation)
 31  (4)   31  (4)   31  (4) 


  Outcome Measures

1.  Primary:   Gestational Weight Gain (GWG)   [ Time Frame: 14-37 weeks ]

2.  Secondary:   Percentage of Participants With Gestational Diabetes   [ Time Frame: 24-26 weeks ]

3.  Secondary:   Fasting Glucose   [ Time Frame: 14-37 wks ]

4.  Secondary:   High-density Lipoprotein (HDL)   [ Time Frame: 14-37 wks ]

5.  Secondary:   Low-density Lipoprotein (LDL)   [ Time Frame: 14-37 weeks ]

6.  Secondary:   Total Cholesterol   [ Time Frame: 14-37 Weeks ]

7.  Secondary:   Triglycerides   [ Time Frame: 14-37 Weeks ]

8.  Secondary:   Leptin   [ Time Frame: 14-37 weeks ]

9.  Secondary:   Steady State Beta Cell Function   [ Time Frame: baseline (14 weeks) and 35-37 weeks ]

10.  Secondary:   Insulin Sensitivity   [ Time Frame: baseline(14 weeks) and 35-37 weeks ]

11.  Secondary:   Insulin Resistance (IR)   [ Time Frame: Baseline (14 weeks) and 35 weeks ]

12.  Secondary:   Birth Weight   [ Time Frame: Delivery ]

13.  Secondary:   Birth Length   [ Time Frame: Delivery ]

14.  Secondary:   Head Circumference   [ Time Frame: Delivery ]

15.  Secondary:   Neonate Percent Body Fat   [ Time Frame: Delivery ]

16.  Secondary:   Infant Weight   [ Time Frame: 1 year ]

17.  Secondary:   Infant Length   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study recruited 281 participants, fewer than the target sample size of 300; this did not impact power for the primary outcome (higher retention rates), but requires attention when considering translational implications to a clinic setting.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary J. Kwasny
Organization: Northwestern University
phone: 312-503-2294
e-mail: m-kwasny@northwestern.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Linda Van Horn, Northwestern University
ClinicalTrials.gov Identifier: NCT01631747     History of Changes
Other Study ID Numbers: DK10-014
1U01HL114344-01 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2012
First Posted: June 29, 2012
Results First Submitted: July 26, 2018
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018