Weight GainNCT03057808
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
A study testing Gestational weight gain intervention and Postpartum weight loss intervention in people with Weight Gain and Weight Loss, run by University of Tennessee at 2 sites in United States.
Trial summary
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Weight Loss
- What is being tested?
- Gestational weight gain intervention and Postpartum weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Feb 2017to 26 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be active duty military, dependents or retired with TRICARE benefits
- Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
- Participants also must be within the normal, overweight, or obese BMI ranges
- Are generally in good health
- Currently not smoking more than 5 cigarettes per day at the time of conception
Who cannot join
- Expecting multiple babies (e.g. twins)
- Diabetic
- Not interested in participating in a program for 21 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
San Antonio, Texas, 78219
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, 78236
About this study
Official title: Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.
Read the detailed description
Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL.
Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized.
Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.
- Conditions
- Weight Gain, Weight Loss
- Being tested
- Gestational weight gain intervention, Postpartum weight loss intervention
- Keywords
- Pregnancy, Postpartum
- Medical subject headings
- Weight Gain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational weight gain interventionBehavioural
Also called GWG-only
This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
Postpartum weight loss interventionBehavioural
Also called PPWL-only
The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
| Study group | Role | What they receive |
|---|---|---|
| Gestational weight gain intervention (GWG-only) | Experimental | The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child. Receives: Behavioral: Gestational weight gain intervention |
| Postpartum weight loss intervention (PPWL-only) | Experimental | The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum. Receives: Behavioral: Postpartum weight loss intervention |
| Combined | Experimental | During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group. Receives: Behavioral: Gestational weight gain intervention; Behavioral: Postpartum weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Mother's Body Weight Pre and Post Pregnancy
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).
Measured: Baseline to 6 months postpartum
Secondary outcomes (8)
Maternal and Fetal Conditions During Pregnancy
Pregnancy-related medical outcomes will be obtained from the participant's medical record and will include: maternal (e.g., gestational diabetes, preeclampsia) and fetal conditions.
Measured: Baseline (13 weeks gestational to delivery)
Birth Weight of Infant
Birth weight of the infant will be recorded in grams.
Measured: Delivery
Length of Infant
Birth height of the infant will be recorded in centimeters.
Measured: Delivery
Waist Circumference on Fitness Test Scores
Waist circumference will be recorded in centimeters.
Measured: Baseline and 12 months postpartum
Number of Push Ups on Fitness Test Scores
Number of push ups completed.
Measured: Baseline and 12 months postpartum
Number of Sit Ups on Fitness Test Scores
Number of sit ups completed.
Measured: Baseline and 12 months postpartum
1.5 Mile Run on Fitness Test Scores
The amount of time it took to complete 1.5 miles.
Measured: Baseline and 12 months postpartum
Moms Fit 2 Fight Program Evaluation Form
Program satisfaction will be assessed using the Investigators program evaluation form to offer insight into program acceptability as well as barriers and facilitators to participation in each intervention arm. Participants will be given 10 statements to rate their experience using a 5 point scale.
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start6 Feb 2017
- Primary completion10 Nov 2021
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- 59th Medical Wing, San Antonio Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Rebecca Krukowski, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057808
- Sponsor's protocol ID
- 16-04804-XP DOD
- Other IDs
- 1R01DK104872-01A1
- Status last verified
- Jul 2022
- First submitted
- 3 Jan 2017
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solomon E, McPhail A, Bursac Z, Little MA, Talcott GW, Krukowski RA. Provider advice, pregnant persons' expectations, and actual gestational weight gain among United States military health care beneficiaries: a secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Nov 25;24(1):785. doi: 10.1186/s12884-024-06987-x.
PubMed 39587506Perez-Munoz A, Hare ME, Andres A, Klesges RC, Wayne Talcott G, Little MA, Waters TM, Harvey JR, Bursac Z, Krukowski RA. A Postpartum Weight Loss-focused Stepped-care Intervention in a Military Population: A Randomized Controlled Trial. Ann Behav Med. 2023 Sep 13;57(10):836-845. doi: 10.1093/abm/kaad014.
PubMed 37061829Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2.
PubMed 36336697Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30.
PubMed 36041980
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
- ClinicalTrials.gov ID
- NCT03057808
- Acronym / sponsor ID
- 16-04804-XP DOD
- Conditions
- Weight Gain, Weight Loss
- Keywords
- Pregnancy, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- 59th Medical Wing, San Antonio Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.
Detailed description
Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL.
Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized.
Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gestational weight gain intervention (GWG-only) | Experimental | Behavioral: Gestational weight gain interventionThe GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child. |
| Postpartum weight loss intervention (PPWL-only) | Experimental | Behavioral: Postpartum weight loss interventionThe PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum. |
| Combined | Experimental | Behavioral: Gestational weight gain intervention, Behavioral: Postpartum weight loss interventionDuring the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be active duty military, dependents or retired with TRICARE benefits
- Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
- Participants also must be within the normal, overweight, or obese BMI ranges
- Are generally in good health
- Currently not smoking more than 5 cigarettes per day at the time of conception
Key exclusion criteria (3 listed)
- Expecting multiple babies (e.g. twins)
- Diabetic
- Not interested in participating in a program for 21 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gestational weight gain interventionAlso: GWG-onlyThis intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving. | Behavioural | Combined, Gestational weight gain intervention (GWG-only) |
| Postpartum weight loss interventionAlso: PPWL-onlyThe PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving. | Behavioural | Combined, Postpartum weight loss intervention (PPWL-only) |
Primary outcome
Changes in the Mother's Body Weight Pre and Post Pregnancy
Time frame: Baseline to 6 months postpartum
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).
8 secondary outcomes
Maternal and Fetal Conditions During Pregnancy
Time frame: Baseline (13 weeks gestational to delivery)
Birth Weight of Infant
Time frame: Delivery
Length of Infant
Time frame: Delivery
Waist Circumference on Fitness Test Scores
Time frame: Baseline and 12 months postpartum
Number of Push Ups on Fitness Test Scores
Time frame: Baseline and 12 months postpartum
Number of Sit Ups on Fitness Test Scores
Time frame: Baseline and 12 months postpartum
1.5 Mile Run on Fitness Test Scores
Time frame: Baseline and 12 months postpartum
Moms Fit 2 Fight Program Evaluation Form
Time frame: 12 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39587506Solomon E, McPhail A, Bursac Z, Little MA, Talcott GW, Krukowski RA. Provider advice, pregnant persons' expectations, and actual gestational weight gain among United States military health care beneficiaries: a secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Nov 25;24(1):785. doi: 10.1186/s12884-024-06987-x.
- Derived from this study: PubMed 37061829Perez-Munoz A, Hare ME, Andres A, Klesges RC, Wayne Talcott G, Little MA, Waters TM, Harvey JR, Bursac Z, Krukowski RA. A Postpartum Weight Loss-focused Stepped-care Intervention in a Military Population: A Randomized Controlled Trial. Ann Behav Med. 2023 Sep 13;57(10):836-845. doi: 10.1093/abm/kaad014.
- Derived from this study: PubMed 36336697Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2.
- Derived from this study: PubMed 36041980Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Krukowski, PhD principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gestational weight gain intervention and Postpartum weight loss intervention in people with Weight Gain and Weight Loss, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Mother's Body Weight Pre and Post Pregnancy (time frame: Baseline to 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057808, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.