Maternal Obesity Complicating Pregnancy, Birth,or PuerperiumNCT06750120
Addressing the Double Burden of Malnutrition in Guatemala
A study testing Family food ration and Optimal weight counseling in people with Maternal Obesity Complicating Pregnancy, Birth,or Puerperium and Child Malnutrition, run by Brigham and Women's Hospital at 1 site in Guatemala.
Trial summary
Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight/obesity and child stunting in the same household. This study will evaluate an integrated intervention combining food supplementation for pregnant and postpartum women and their infants with… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Child Malnutrition
- What is being tested?
- Family food ration and Optimal weight counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,532 participants
- Where
- 1 siteGuatemala
- Study dates
- 14 May 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women aged 16 years or older
- Gestational age less than 28 weeks
Who cannot join
- History of pregestational diabetes (type 1 or type 2), history of gestational diabetes in a previous pregnancy, or diagnosis of gestational diabetes in the current pregnancy
- Multifetal gestation (twins or higher-order pregnancies)
- Currently participating in another research study involving an intervention
- Has a family member who has already been invited to participate in this study and/or shares a kitchen with such a person
- Has a serious underlying medical or psychiatric condition requiring specialized clinical care, including active cancer, severe renal or hepatic disease, symptomatic heart disease, autoimmune disorders requiring immunosuppressive therapy, active thromboembolism or coagulopathy, or severe mental health condition, or other conditions at the discretion of the investigators
- Plans to move out of the study area within the next two years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guatemala1 site, 1 recruiting
- Recruiting
Community recruitment
Tecpán Guatemala, Departamento de Chimaltenango
Peter Rohloff
About this study
Official title: An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala
Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight/obesity and child stunting in the same household. This study will evaluate an integrated intervention combining food supplementation for pregnant and postpartum women and their infants with behavioral counseling to promote healthy maternal weight, nutrition, physical activity, and infant feeding practices. The goal is to reduce the double burden of malnutrition in rural Indigenous communities in Guatemala.
Read the detailed description
K'ASLEM (meaning "life" in the Kaqchikel Mayan language) is an individually randomized, parallel-group Hybrid Type 1 effectiveness-implementation clinical trial conducted in Indigenous Maya communities in Guatemala that have among the world's highest levels of double burden of malnutrition. The trial will enroll 766 pregnant women aged 16 years or older before 28 weeks gestation with 1:1 allocation to intervention and comparator arms. The intervention arm will receive two integrated interventions: (a) food supplementation for pregnant and postpartum women and for infants and (b) behavioral counseling to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. The comparator is enhanced usual care, which includes routine government prenatal and postnatal services along with care navigation and provision of fortified flour for infants. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age at 12 months after birth. Complementing these trial outcomes, the study will collect mixed-methods data on implementation outcomes and apply implementation mapping to develop strategies for future scale-up. The trial will also include an economic evaluation to inform policymakers of costs and cost-effectiveness. A major feature of the trial is a focus on pragmatism and fairness, working to enroll vulnerable families from rural Guatemala who stand most to benefit from the intervention but who are commonly excluded from clinical trials.
- Being tested
- Family food ration, Optimal weight counseling, Enhanced Usual Care
- Keywords
- Guatemala, stunting, maternal obesity, food supplementation, lifestyle counseling, child malnutrition
- Medical subject headings
- Child Nutrition Disorders, Growth Disorders, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family food rationDietary supplement
Monthly household food rations containing 5 food groups (eggs, fortified blended flour, oil, legumes, and fresh fruits and vegetables), providing approximately 150 kcal per capita per day assuming a median household of 5.
Optimal weight counselingBehavioural
Individually tailored monthly home visits by trained educators addressing healthy gestational weight gain, postpartum weight management, maternal nutrition, physical activity, and infant feeding practices.
Enhanced Usual CareOther
Usual care: Free pregnancy, postnatal, and infant care through the Ministry of Health services, including vitamin supplementation, infant vaccinations, and growth monitoring. Enhancements: Care navigation for high-risk or emergency conditions and ensuring infants aged 6 to 12 months receive government-recommended fortified blended flour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive two integrated interventions from enrollment through 12 months postpartum. (1) Food supplementation: Monthly household food rations containing 5 food groups, designed to address dietary quality gaps for both mothers and infants; and (2) Behavioral counseling: Individually tailored monthly home visits by trained educators to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. Participants in the intervention arm will also receive enhanced usual care as described for the comparator arm. Receives: Dietary Supplement: Family food ration; Behavioral: Optimal weight counseling; Other: Enhanced Usual Care |
| Enhanced Usual Care Arm | Active comparator | The comparator is enhanced usual care. Usual care includes free pregnancy, postnatal, and infant care through the Ministry of Health services. Two enhancements are provided: (1) Enrollment in Maya Health Alliance's care navigation program, which supports women and infants with high-risk or emergency conditions; and (2) Ensuring that infants aged 6 to 12 months receive the government-recommended monthly provision of fortified blended flour. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child length-for-age z score
Mean length-for-age z score (LAZ) at 12 months of age using WHO Child Growth Standards
Measured: 12 months of age
Maternal weight
Mean maternal weight in kilograms at 12 months postpartum
Measured: 12 months postpartum
Secondary outcomes (4)
Child stunting
Proportion of children with length-for-age z score less than -2 using WHO Child Growth Standards
Measured: 12 months of age
Child global development score
Mean overall global development raw scaled (factor) score from the Caregiver Reported Early Development Instruments (CREDI) long form (range 0 to 117, higher scores indicate more advanced development)
Measured: 12 months of age
Maternal overweight/obesity
Proportion of women with body mass index 25 kg/m^2 or greater
Measured: 12 months postpartum
Maternal hemoglobin
Mean hemoglobin concentration in g/dL
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 posted27 Dec 2024
- Study start14 May 2026
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Obesity Complicating Pregnancy, Birth,or PuerperiumStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, Instituto de Nutricion de Centroamerica y Panama (INCAP), University of Michigan, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Peter J. Rohloff, M.D.,Ph.D., Brigham and Women's Hospital
- Investigators
- Peter Rohloff, MD PhD, Principal investigator, Brigham and Women's HospitalManuel Ramirez, MD PhD, Principal investigator, Institute of Nutrition of Central America and PanamaDavid Flood, MD MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750120
- Sponsor's protocol ID
- 2024P003339
- Status last verified
- May 2026
- First submitted
- 12 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published primary and secondary analyses, including demographic, anthropometric, laboratory, and questionnaire data.
Publications
Popkin BM, Corvalan C, Grummer-Strawn LM. Dynamics of the double burden of malnutrition and the changing nutrition reality. Lancet. 2020 Jan 4;395(10217):65-74. doi: 10.1016/S0140-6736(19)32497-3. Epub 2019 Dec 15.
PubMed 31852602
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Intervention to Address the Double Burden of Malnutrition in Guatemala
- ClinicalTrials.gov ID
- NCT06750120
- Acronym / sponsor ID
- 2024P003339
- Keywords
- Guatemala, stunting, maternal obesity, food supplementation, lifestyle counseling, child malnutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,532 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, Instituto de Nutricion de Centroamerica y Panama (INCAP), University of Michigan, Harvard Medical School (HMS and HSDM)
- Study start
- 14 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight/obesity and child stunting in the same household. This study will evaluate an integrated intervention combining food supplementation for pregnant and postpartum women and their infants with behavioral counseling to promote healthy maternal weight, nutrition, physical activity, and infant feeding practices. The goal is to reduce the double burden of malnutrition in rural Indigenous communities in Guatemala.
Detailed description
K'ASLEM (meaning "life" in the Kaqchikel Mayan language) is an individually randomized, parallel-group Hybrid Type 1 effectiveness-implementation clinical trial conducted in Indigenous Maya communities in Guatemala that have among the world's highest levels of double burden of malnutrition. The trial will enroll 766 pregnant women aged 16 years or older before 28 weeks gestation with 1:1 allocation to intervention and comparator arms. The intervention arm will receive two integrated interventions: (a) food supplementation for pregnant and postpartum women and for infants and (b) behavioral counseling to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. The comparator is enhanced usual care, which includes routine government prenatal and postnatal services along with care navigation and provision of fortified flour for infants. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age at 12 months after birth. Complementing these trial outcomes, the study will collect mixed-methods data on implementation outcomes and apply implementation mapping to develop strategies for future scale-up. The trial will also include an economic evaluation to inform policymakers of costs and cost-effectiveness. A major feature of the trial is a focus on pragmatism and fairness, working to enroll vulnerable families from rural Guatemala who stand most to benefit from the intervention but who are commonly excluded from clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Dietary Supplement: Family food ration, Behavioral: Optimal weight counseling, Other: Enhanced Usual CareParticipants will receive two integrated interventions from enrollment through 12 months postpartum. (1) Food supplementation: Monthly household food rations containing 5 food groups, designed to address dietary quality gaps for both mothers and infants; and (2) Behavioral counseling: Individually tailored monthly home visits by trained educators to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. Participants in the intervention arm will also receive enhanced usual care as described for the comparator arm. |
| Enhanced Usual Care Arm | Active comparator | Other: Enhanced Usual CareThe comparator is enhanced usual care. Usual care includes free pregnancy, postnatal, and infant care through the Ministry of Health services. Two enhancements are provided: (1) Enrollment in Maya Health Alliance's care navigation program, which supports women and infants with high-risk or emergency conditions; and (2) Ensuring that infants aged 6 to 12 months receive the government-recommended monthly provision of fortified blended flour. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women aged 16 years or older
- Gestational age less than 28 weeks
Key exclusion criteria (6 listed)
- History of pregestational diabetes (type 1 or type 2), history of gestational diabetes in a previous pregnancy, or diagnosis of gestational diabetes in the current pregnancy
- Multifetal gestation (twins or higher-order pregnancies)
- Currently participating in another research study involving an intervention
- Has a family member who has already been invited to participate in this study and/or shares a kitchen with such a person
- Has a serious underlying medical or psychiatric condition requiring specialized clinical care, including active cancer, severe renal or hepatic disease, symptomatic heart disease, autoimmune disorders requiring immunosuppressive therapy, active thromboembolism or coagulopathy, or severe mental health condition, or other conditions at the discretion of the investigators
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 |
|---|---|---|
| Family food rationMonthly household food rations containing 5 food groups (eggs, fortified blended flour, oil, legumes, and fresh fruits and vegetables), providing approximately 150 kcal per capita per day assuming a median household of 5. | Dietary supplement | Intervention Arm |
| Optimal weight counselingIndividually tailored monthly home visits by trained educators addressing healthy gestational weight gain, postpartum weight management, maternal nutrition, physical activity, and infant feeding practices. | Behavioural | Intervention Arm |
| Enhanced Usual CareUsual care: Free pregnancy, postnatal, and infant care through the Ministry of Health services, including vitamin supplementation, infant vaccinations, and growth monitoring. Enhancements: Care navigation for high-risk or emergency conditions and ensuring infants aged 6 to 12 months receive government-recommended fortified blended flour. | Other | Enhanced Usual Care Arm, Intervention Arm |
Primary outcome
Child length-for-age z score
Time frame: 12 months of age
Mean length-for-age z score (LAZ) at 12 months of age using WHO Child Growth Standards
Maternal weight
Time frame: 12 months postpartum
Mean maternal weight in kilograms at 12 months postpartum
4 secondary outcomes
Child stunting
Time frame: 12 months of age
Child global development score
Time frame: 12 months of age
Maternal overweight/obesity
Time frame: 12 months postpartum
Maternal hemoglobin
Time frame: 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31852602Popkin BM, Corvalan C, Grummer-Strawn LM. Dynamics of the double burden of malnutrition and the changing nutrition reality. Lancet. 2020 Jan 4;395(10217):65-74. doi: 10.1016/S0140-6736(19)32497-3. Epub 2019 Dec 15.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published primary and secondary analyses, including demographic, anthropometric, laboratory, and questionnaire data.
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.
Peter Rohloff, MD PhD principal investigator
Brigham and Women's Hospital
Manuel Ramirez, MD PhD principal investigator
Institute of Nutrition of Central America and Panama
David Flood, MD MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family food ration and Optimal weight counseling in people with Maternal Obesity Complicating Pregnancy, Birth,or Puerperium and Child Malnutrition, run by Brigham and Women's Hospital at 1 site in Guatemala.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Rohloff, MD PhD (617-732-5500, prohloff@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child length-for-age z score (time frame: 12 months of age). The study lists 2 primary outcomes in all. 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 NCT06750120, which also lists 1 linked publication.
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 22 May 2026.