Dietary Intervention for Postpartum Weight Retention

(PADaWL Trial)

Recruiting at 1 trial location

Overseen By Chothika Mekonnen, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Tripler Army Medical Center

Disqualifiers: Obesity, Preterm delivery, Severe morbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 12 months

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dietary changes can help active duty women lose weight after giving birth, particularly during the first year postpartum. Participants will be divided into groups: one will receive targeted dietary counseling (behavioral therapy for eating behaviors), another will have supervised diet, exercise, and sleep, and the last group will receive routine postpartum care. The goal is to determine which approach best helps participants meet military fitness standards. Ideal candidates are women on active duty who have had their first child and plan to remain on active duty without a break for at least 18 months.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve postpartum health and military readiness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on diet and exercise for postpartum weight loss.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that dietary counseling is generally safe. For example, studies on nutrition counseling for pregnant women found it improved their diet without causing harm. Another study suggested that adding nutritional counseling to other treatments helped people lose weight safely.

Behavioral counseling for weight management also seems well-tolerated, according to findings from the U.S. Preventive Services Task Force. They found that this type of counseling helped people lose weight without major side effects.

In summary, current evidence suggests that dietary counseling and behavioral interventions are safe and well-tolerated, with no significant reports of negative effects from these approaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how dietary counseling might play a crucial role in managing postpartum weight retention. Unlike standard postpartum care, which typically includes general dietary advice, this approach involves personalized dietary counseling coupled with close monitoring of diet, exercise, and sleep. By tailoring interventions to individual behaviors and needs, this method could provide more sustainable and effective weight management solutions for new mothers. The trial also examines the impact of close supervision alone, offering valuable insights into different strategies for postpartum care.

What evidence suggests that this trial's dietary interventions could be effective for postpartum weight retention?

This trial will compare different approaches to postpartum weight management. Research has shown that changing eating habits can help new mothers lose weight. One study found that a program focused on changing diet habits helped women lose weight both shortly after childbirth and in the long run. In this trial, participants in Intervention Arm 1 will receive dietary counseling aimed at modifying eating behaviors, along with supervision of diet, exercise, and sleep. Another study found that using a mobile app to support behavior change also led to significant weight loss after having a baby. Participants in Intervention Arm 2 will have close supervision of diet, exercise, and sleep without dietary counseling. These findings suggest that guided changes in diet can effectively manage weight after childbirth. Focusing on nutrition can be crucial in helping women achieve their weight goals during this time. ^{1 2 6 7 8}

Who Is on the Research Team?

Alan P Gehrich, MD

Principal Investigator

Tripler Army Medical Center

Are You a Good Fit for This Trial?

This trial is for active duty women from any military service who are experiencing their first pregnancy, have a BMI under 30 in the first trimester, and plan to remain on active duty for at least 18 months post-delivery. They must not be planning another pregnancy within that time and should stay on Oahu for at least 12 months after giving birth.

Inclusion Criteria

Not planning short interval pregnancy within 18 months of delivery

Active Duty from any service - Army, Navy, Air Force, Marine, Coast Guard

Any type of delivery (spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery)

Exclusion Criteria

My newborn was in the NICU for more than 2 weeks.

No physical fitness test for record in the year prior to pregnancy

Delivery before 36 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Eligible participants meet with the research team, provide consent, and are randomized into study groups

1 week

1 visit (in-person)

Treatment

Participants receive dietary intervention and monitoring of diet, exercise, and sleep for the first 12 months postpartum

12 months

Weekly virtual sessions for the first 12 weeks, then at 6, 9, and 12 months

Intensive Data Collection

Intensive data collection on diet, activity, and sleep using biometric devices and web-based diaries

12 weeks

Weekly data submission

Follow-up

Participants are monitored for weight and fitness outcomes at 6, 9, and 12 months postpartum

12 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Counseling with goal of modifying eating behaviors

Trial Overview The study tests if counseling with a dietician can help new mothers return to pre-pregnancy weight and meet military fitness standards faster than usual care. Participants will get weekly virtual sessions with a dietician for the first year postpartum, alongside monitoring of activity levels, sleep, breastfeeding habits, diet, and depression.

How Is the Trial Designed?

Group I: Intervention Arm 2 Experimental Treatment 1 Intervention

Women in this arm will not have dietary counseling but will have close supervision of diet, exercise and sleep.

Group II: Intervention Arm 1 Experimental Treatment 1 Intervention

Women in this arm will undergone dietary counseling in the first year postpartum in addition to close supervision of diet, exercise, and sleep.

Group III: Control Active Control 1 Intervention

Women in this arm will undergo routine postpartum care.

Who Is Running the Clinical Trial?

Tripler Army Medical Center

Lead Sponsor

Trials

23

Recruited

27,900+

Published Research Related to This Trial

Cognitive-behavioral weight management programs effectively promote healthier dietary and lifestyle changes in obese individuals without requiring drastic weight loss, focusing on modifying behaviors linked to health and psychological well-being.

These interventions are particularly beneficial for overweight adolescents, helping them cope with social stigma, improve self-esteem, and enhance body image satisfaction, especially when delivered before puberty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approaches in the management of obesity. Wisotsky, W., Swencionis, C.[2018]

The patient-centered counseling model improves long-term dietary adherence by personalizing interventions based on individual patient needs and stages of change.

This model includes a 4-step counseling process that helps nutrition professionals effectively support patients in following nutrition care plans and dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. Rosal, MC., Ebbeling, CB., Lofgren, I., et al.[2022]

Personalized nutritional advice through one-on-one conversations is effective in identifying and addressing specific eating behaviors to reduce nutrition-related risks.

Interactive group sessions are particularly beneficial for providing nutritional advice for various nutrition-related diseases, enhancing support and engagement among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Strategies in practical nutrition counseling]. Weberhofer, CM., Held, C.[2009]

A short-term intensive nutritional counseling program significantly improved glycemic control in 75% of patients with type 2 diabetes, compared to only 31.6% in the conventional treatment group, highlighting the efficacy of structured dietary interventions.

Increased fiber intake was associated with better blood glucose control, suggesting that dietary adjustments, particularly in fiber consumption, play a crucial role in managing hyperglycemia in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of nutritional counseling and dietary fiber content on glycemic control in type 2 diabetic patients under intensive educational intervention]. Carvalho, FS., Pimazoni Netto, A., Zach, P., et al.[2019]

A pilot study involving 26 low-income postpartum women in Brazil showed that nutritional counseling based on the DASH diet significantly reduced postpartum weight retention by an average of 1.80 kg over three months.

Participants also experienced reductions in body mass index and waist circumference, with 91.67% demonstrating good adherence to the dietary recommendations, highlighting the effectiveness of nutritional support in primary health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot intervention to reduce postpartum weight retention at primary health care in Brazil. Santos, KD., Patrício, PT., Lima, TSV., et al.[2022]

Breastfeeding women on special diets, such as weight-loss or vegetarian diets, as well as those with eating disorders like anorexia or bulimia, require nutritional counseling to mitigate dietary risks.

Current research is insufficient to fully understand how a lactating woman's nutrition impacts both her health and her child's health, highlighting the need for further studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets and eating disorders: implications for the breastfeeding mother. Weekly, SJ.[2015]

A behavioral lifestyle intervention for pregnant women with overweight and obesity led to significantly less weight retention at 6 months (-3.6 kg) and 12 months (-2.4 kg) postpartum compared to standard care, based on a study of 219 participants.

Women in the intervention group had 2.3 times higher odds of not retaining any weight at 6 months postpartum and lower odds of retaining 5% or more of their prepregnancy weight, indicating the intervention's effectiveness in promoting healthier weight outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. Liu, J., Wilcox, S., Hutto, B., et al.[2022]

Weight retention and gain during the postpartum and midlife periods can lead to chronic health issues, highlighting the importance of effective weight management strategies for women during these times.

Healthcare professionals, including physicians and obstetricians, should provide tailored dietary advice that considers individual calorie needs, macronutrient distribution, and cultural preferences to support sustainable weight management in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stepwise Approach to Prescribe Dietary Advice for Weight Management in Postpartum and Midlife Women. Malhotra, A., Verma, A., Kaur, D., et al.[2023]

A postpartum lifestyle intervention involving nutrition, exercise, and mental well-being coaching led to significant weight loss and improved body composition in women with excessive gestational weight gain, with a completion rate of 76% among 1075 participants.

Women who reduced their energy intake and improved their eating behaviors experienced greater decreases in weight, fat percentage, and waist circumference, highlighting the importance of dietary changes in achieving better postpartum outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the e-health supported INTER-ACT lifestyle intervention on postpartum weight retention and body composition, and associations with lifestyle behavior: A randomized controlled trial. Van Uytsel, H., Bijlholt, M., Devlieger, R., et al.[2022]

A systematic review of 214 articles identified strong evidence supporting the use of cognitive behavioral therapy (CBT) combined with behavioral theories to effectively change dietary habits and reduce risks for conditions like type 2 diabetes, particularly in patients undergoing intensive CBT for 6 to 12 months.

Motivational interviewing emerged as a highly effective counseling strategy, especially when paired with CBT, while strategies like financial rewards were found to be ineffective, highlighting the importance of goal setting and social support in nutrition counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the evidence regarding behavior change theories and strategies in nutrition counseling to facilitate health and food behavior change. Spahn, JM., Reeves, RS., Keim, KS., et al.[2022]

Manual-based cognitive-behavioral therapy (CBT) and nutritional counseling both aim to eliminate unhealthy eating patterns, but require specialized training in behavior change that many nutritionists and mental health professionals may lack.

Nutritional rehabilitation programs can enhance CBT by specifically targeting the appetitive and metabolic abnormalities seen in eating disorders like bulimia nervosa and binge eating disorder, potentially leading to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy and nutritional counseling in the treatment of bulimia nervosa and binge eating. Latner, JD., Wilson, GT.[2019]

Behavior therapy, even without formal nutrition counseling, can effectively lead to weight loss and reduced calorie intake, as shown in a study analyzing eating diaries of participants.

Both behavior therapy and relaxation-medication treatments resulted in participants maintaining a nutritious diet while consuming less food, indicating that these approaches can support healthy eating habits during weight control efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of behavioral and pharmacological weight loss programs on nutrient intake. Brightwell, DR., Foster, D., Lee, S., et al.[2018]

Citations

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Effectiveness of a weight loss intervention in postpartum ... This study was designed to evaluate the short- and long-term effectiveness of a diet behavior modification treatment to produce weight loss in postpartum women.

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Effectiveness of nutrition counseling for pregnant women in low Nutrition counseling may improve caloric, protein, and fat intake, gestational weight gain, and reduce hemorrhage, but has little to no effect ...

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Effectiveness of nutrition literacy intervention on pregnancy ... The comprehensive nutritional literacy intervention implemented in early pregnancy significantly improved pregnant women's nutritional literacy levels.

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Postpartum Weight Retention: A Retrospective Data ... This cohort study shows that a uniquely mobile, behavior change intervention for weight management is effective at producing significant weight loss.

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Medical Nutrition Therapy Interventions Provided by ... The objective of this evidence-based practice guideline is to provide recommendations for dietitians who deliver medical nutrition therapy behavioral ...

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Effects of Breastfeeding Promotion Intervention and Dietary ... There were no effects of BPI on body weight or cardiometabolic risk factors at 6 mo postpartum. Diet caused weight loss and had favorable effects on risk ...

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Behavioral Counseling Interventions for Healthy Weight ... The USPSTF found adequate evidence that behavioral counseling interventions demonstrated reductions in intermediate outcomes, including ...