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Tools For Teen Moms: Reducing Infant Obesity Risk (TFTM)

2019年3月6日 更新者:Mildred Horodynski、Michigan State University

Tools for Teen Moms: Reducing Infant Obesity Risk

The purpose of this social media group randomized trial (GRT) is to test the feasibility of our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues and implement healthy feeding practices through development of a healthy feeding style.

Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered to the target population as it relates to their acceptance and satisfaction with the content, format, delivery, and use of social media.

Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and feeding practices evaluated at the completion of the intervention using self-report methods.

調査の概要

詳細な説明

Rapid weight gain during infancy is one of the strongest risk factors for obesity later in childhood. Weight gain in infancy is closely linked with feeding practices. Unhealthy mother-infant feeding practices contribute to rapid and/or excessive infant weight gain. Lower-income, adolescent, first-time mothers are less likely to engage in infant-centered feeding (ICF) which is characterized by maternal responsiveness (MR), healthy feeding styles (FS), and healthy feeding practices (FP). ICF is needed to reduce rapid/excessive weight gain during the first six months of life and to foster infant feeding self-regulation that is associated with healthy growth. ICF is a critical factor in reducing infant obesity risk and later adverse health conditions. Practical early intervention strategies are necessary to promote ICF among adolescent mothers to reduce obesity risk. We propose Baby Dayr, a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, an infant feeding website, and Facebook to increase ICF through daily behavioral challenge activities ("challenges") for this population. Because cell phones permit natural, frequent and non-intrusive contact as they are not time-or-place-dependent, they offer an innovative strategy for intervening with adolescent mothers. However, this approach is untested for its feasibility with this population regarding infant feeding practices. We propose an exploratory, longitudinal, randomized, two-group study design. The three specific aims are: 1) to establish preliminary efficacy of the intervention as assessed by infant growth evaluated pre-intervention, immediately post intervention, and when the infant is six months old; 2) establish preliminary efficacy of the Baby Dayr plus Maternal-Infant Health Program (MIHP) care vs. MIHP care only on infant-centered feeding (MR, FS, and FP) mediated by maternal knowledge and self-efficacy; and 3) establish the feasibility, acceptability, and satisfaction of a social media intervention (Baby Dayr) for low-income adolescent, first-time mothers by assessing: 1) rates of enrollment and completion of daily challenges, 2) acceptability ratings of Baby Dayr; and 3) satisfaction with Baby Dayr. Participants will be randomly assigned to the intervention (Baby Dayr and MIHP) (n = 40) or control group (MIHP care only) (n = 40). The intervention consists of six weeks of daily challenges and will be delivered starting when the infant is four to six weeks old. The study is innovative in its: 1) assessment of ICF to reduce rapid/excessive infant weight gain in the first six months of life with low-income, adolescent, first-time mother-infant dyads, and 2) combination of an infant-centered skill-building, educational, and coaching approach using social media that is accessible and suitable for adolescents. The proposed research is significant in that it will contribute to the science related to ICF and knowledge regarding use of a social media platform in an at-risk population that can lead to reducing the risk of infant obesity. Information gained from this study will be used to refine the intervention for use in a larger-scale, longitudinal, randomized, controlled trial to reduce obesity risk in infants of low-income, adolescent mothers.

研究の種類

介入

入学 (実際)

164

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Michigan
      • East Lansing、Michigan、アメリカ、48824
        • Michigan State University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年~19年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Self-identified, English-speaking
  • Low-income, adolescent
  • First-time mothers between the ages of 14 and 19
  • With daily web access and access to a cell phone that includes text messaging capabilities
  • Family income ≤ 185% of federal poverty
  • Term birth (37≤42 weeks, 2500≤3750 grams birth weight)
  • Mothers and infants with no special nutrients or feeding needs
  • Infants less than six weeks old at study enrollment who have not started eating solid foods
  • Adolescent mothers must be a primary caretaker of the infant who feeds her infant at least once a day, and who is willing to participate in a six-week intervention with data collection at three defined time points (T1, T2, and T3)

Exclusion Criteria:

  • Male caregivers
  • Mothers and infants with diagnosed feeding/eating disorders
  • Significant perinatal or postnatal complications
  • Post partum depression or other mental health problems
  • Adolescent mothers who do not share in the feeding responsibility of their infants
  • Adolescents without daily web access nor a cell phone with text messaging capabilities

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Tools for Teen Moms Intervention Group
Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.
The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities ("challenges") for this population. The intervention consists of 6 weeks of daily challenges and will be delivered within the infant's first 6 months of life.
介入なし:MIHP standard care
MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Infant Growth
時間枠:Baby is less than 2 months; baby is 3 months; baby is 6 months
Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.
Baby is less than 2 months; baby is 3 months; baby is 6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Mildred A Horodynski, PhD、Michigan State University
  • 主任研究者:Kami Silk, PhD、Michigan State University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年6月1日

一次修了 (実際)

2016年9月1日

研究の完了 (実際)

2016年9月1日

試験登録日

最初に提出

2014年6月24日

QC基準を満たした最初の提出物

2014年9月16日

最初の投稿 (見積もり)

2014年9月19日

学習記録の更新

投稿された最後の更新 (実際)

2019年3月8日

QC基準を満たした最後の更新が送信されました

2019年3月6日

最終確認日

2019年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 1R21HDO75974-OIAL

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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